Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-28 @ 8:25 PM
Study NCT ID:
NCT01656395
Status:
TERMINATED
Last Update Posted:
2018-09-13
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Canada', 'Chile', 'Colombia', 'France', 'Germany', 'Guatemala', 'Italy', 'Japan', 'Peru', 'Puerto Rico', 'South Africa', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 weeks (Up to 2 weeks after last dose of study drug)', 'description': 'The safety population consisted of all randomized participants who received ≥1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 15, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 24, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'MK-1029 60 mg', 'description': 'Participants receive MK-1029 two 30 mg tablets QD for 12 weeks', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 27, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'MK-1029 150 mg', 'description': 'Participants receive MK-1029 150 mg tablets QD for 12 weeks', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 19, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Montelukast 10 mg', 'description': 'Participants receive Montelukast 10 mg tablets QD for 12 weeks', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 19, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Participants receive Placebo tablets QD for 12 weeks', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 42, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': "Kaposi's varicelliform eruption", 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.065', 'groupId': 'OG000', 'lowerLimit': '-0.009', 'upperLimit': '0.139'}, {'value': '0.004', 'groupId': 'OG001', 'lowerLimit': '-0.075', 'upperLimit': '0.083'}, {'value': '0.063', 'groupId': 'OG002', 'lowerLimit': '-0.019', 'upperLimit': '0.144'}, {'value': '0.036', 'groupId': 'OG003', 'lowerLimit': '-0.04', 'upperLimit': '0.112'}, {'value': '0.039', 'groupId': 'OG004', 'lowerLimit': '-0.033', 'upperLimit': '0.111'}, {'value': '0.043', 'groupId': 'OG005', 'lowerLimit': '-0.032', 'upperLimit': '0.119'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '0.127', 'groupDescription': 'Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.477', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.149', 'ciUpperLimit': '0.07', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.733', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.019', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '0.13', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.89', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.115', 'ciUpperLimit': '0.1', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.935', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.1', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'FEV1 is the amount of air (in liters) forcibly exhaled in one second. Repeated measurements of FEV1 were collected at visits during the 12 week active treatment period and the average change from baseline in FEV1 over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a constrained longitudinal data analysis (cLDA) model. In the cLDA analysis, baseline was the average FEV1 during the placebo run-in period and the post-baseline value was the average FEV1 over Week 6 to Week 12.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'T helper cell type 2 (TH2)-High participants who received ≥1 study drug dose and had FEV1 data.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experience Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '126', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}, {'value': '48.4', 'groupId': 'OG001'}, {'value': '47.4', 'groupId': 'OG002'}, {'value': '53.8', 'groupId': 'OG003'}, {'value': '56.7', 'groupId': 'OG004'}, {'value': '57.9', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinue Study Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '126', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '5.6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received ≥1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asthma Exacerbation Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.704', 'groupId': 'OG000', 'lowerLimit': '10.657', 'upperLimit': '24.75'}, {'value': '15.812', 'groupId': 'OG001', 'lowerLimit': '8.334', 'upperLimit': '23.29'}, {'value': '15.435', 'groupId': 'OG002', 'lowerLimit': '7.752', 'upperLimit': '23.118'}, {'value': '20.238', 'groupId': 'OG003', 'lowerLimit': '13.353', 'upperLimit': '27.124'}, {'value': '19.657', 'groupId': 'OG004', 'lowerLimit': '12.845', 'upperLimit': '26.47'}, {'value': '24.904', 'groupId': 'OG005', 'lowerLimit': '17.424', 'upperLimit': '32.384'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-17.48', 'ciUpperLimit': '3.08', 'groupDescription': 'Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.092', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.092', 'ciLowerLimit': '-19.67', 'ciUpperLimit': '1.485', 'groupDescription': 'Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.083', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.469', 'ciLowerLimit': '-20.19', 'ciUpperLimit': '1.25', 'groupDescription': 'Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.367', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.666', 'ciLowerLimit': '-14.83', 'ciUpperLimit': '5.501', 'groupDescription': 'Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.308', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.247', 'ciLowerLimit': '-15.36', 'ciUpperLimit': '4.871', 'groupDescription': 'Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6 to Week 12', 'description': 'An asthma exacerbation day was defined as a day with ANY of the following: a decrease from Baseline in morning (AM) Peak Expiratory Flow (PEF) of more than 20%, an AM PEF of less than 180 liters (L)/min, an increase in Short Acting Beta2 Agonist (SABA) use of more than 70% (and a minimum increase of at least 2 puffs), an increase from Baseline in Daytime Asthma Symptom Score of more than 50%, an overnight asthma symptom of: Awake "all night", or an asthma attack. Information on asthma exacerbation days was recorded throughout the study in the participant\'s electronic diary (e-Diary), and an Analysis of Variance (ANOVA) was used to calculate the average percentage of days with asthma exacerbations over Week 6 to Week 12.', 'unitOfMeasure': 'Percentage of Asthma Exacerbation Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had asthma exacerbation data.'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline in Daytime Symptom Score (DSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.398', 'groupId': 'OG000', 'lowerLimit': '-0.612', 'upperLimit': '-0.184'}, {'value': '-0.134', 'groupId': 'OG001', 'lowerLimit': '-0.358', 'upperLimit': '0.091'}, {'value': '-0.364', 'groupId': 'OG002', 'lowerLimit': '-0.591', 'upperLimit': '-0.137'}, {'value': '-0.120', 'groupId': 'OG003', 'lowerLimit': '-0.325', 'upperLimit': '0.086'}, {'value': '-0.411', 'groupId': 'OG004', 'lowerLimit': '-0.617', 'upperLimit': '-0.206'}, {'value': '-0.276', 'groupId': 'OG005', 'lowerLimit': '-0.495', 'upperLimit': '-0.056'}]}]}], 'analyses': [{'pValue': '0.429', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.122', 'ciLowerLimit': '-0.427', 'ciUpperLimit': '0.182', 'groupDescription': 'Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.370', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.142', 'ciLowerLimit': '-0.169', 'ciUpperLimit': '0.454', 'groupDescription': 'Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.579', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.089', 'ciLowerLimit': '-0.402', 'ciUpperLimit': '0.225', 'groupDescription': 'Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.305', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.156', 'ciLowerLimit': '-0.142', 'ciUpperLimit': '0.454', 'groupDescription': 'Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.372', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.136', 'ciLowerLimit': '-0.434', 'ciUpperLimit': '0.163', 'groupDescription': 'Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'The Daytime Symptom Score assessed daytime asthma symptoms. In the evening just before going to bed, participants scored their asthma symptoms for the period since arising by answering the following 4 questions in eDiaries: 1) How often did you experience asthma symptoms today?, 2) How much did your asthma symptoms bother you?, 3) How much activity could you do today? and 4) How often did your asthma affect your activities today? The 4 questions were scored on a 7-point scale (0=best to 6=worst) and averaged for a single score. The average change from baseline in DSS over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average DSS score during the placebo run-in period and the post-baseline value was the average DSS Score over Week 6 to Week 12.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had DSS data.'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.373', 'groupId': 'OG000', 'lowerLimit': '-1.847', 'upperLimit': '-0.899'}, {'value': '-0.920', 'groupId': 'OG001', 'lowerLimit': '-1.420', 'upperLimit': '-0.421'}, {'value': '-0.955', 'groupId': 'OG002', 'lowerLimit': '-1.461', 'upperLimit': '-0.450'}, {'value': '-0.571', 'groupId': 'OG003', 'lowerLimit': '-1.031', 'upperLimit': '-0.111'}, {'value': '-1.234', 'groupId': 'OG004', 'lowerLimit': '-1.694', 'upperLimit': '-0.774'}, {'value': '-0.845', 'groupId': 'OG005', 'lowerLimit': '-1.334', 'upperLimit': '-0.356'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.528', 'ciLowerLimit': '-1.184', 'ciUpperLimit': '0.128', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.827', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.075', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.6', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.75', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.789', 'ciUpperLimit': '0.569', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.403', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.275', 'ciLowerLimit': '-0.371', 'ciUpperLimit': '0.921', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.237', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.389', 'ciLowerLimit': '-1.035', 'ciUpperLimit': '0.257', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'Twice daily (upon arising and before going to sleep), participants recorded the total number of puff (actuations) of SABA used for asthma symptoms in their eDiaries. The number of SABA puffs used in one day was calculated based on eDiary entries as the sum of daytime and nighttime number of puffs of SABA. The average change from baseline over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) in the daily number of SABA puffs was estimated using a cLDA model. In the cLDA analysis, Baseline was the average number of SABA puffs used in one day during the placebo run-in period and the post-baseline value was calculated as the average number of SABA puffs used in one day over Week 6 to Week 12.', 'unitOfMeasure': 'Number of SABA Puffs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had SABA usage data.'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline in Number of Nocturnal Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.277', 'groupId': 'OG000', 'lowerLimit': '-1.861', 'upperLimit': '-0.692'}, {'value': '-0.900', 'groupId': 'OG001', 'lowerLimit': '-1.518', 'upperLimit': '-0.282'}, {'value': '-1.286', 'groupId': 'OG002', 'lowerLimit': '-1.912', 'upperLimit': '-0.661'}, {'value': '-1.277', 'groupId': 'OG003', 'lowerLimit': '-1.844', 'upperLimit': '-0.710'}, {'value': '-1.107', 'groupId': 'OG004', 'lowerLimit': '-1.674', 'upperLimit': '-0.540'}, {'value': '-1.036', 'groupId': 'OG005', 'lowerLimit': '-1.639', 'upperLimit': '-0.432'}]}]}], 'analyses': [{'pValue': '0.565', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.241', 'ciLowerLimit': '-1.066', 'ciUpperLimit': '0.583', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.754', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.135', 'ciLowerLimit': '-0.713', 'ciUpperLimit': '0.983', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.563', 'groupIds': ['OG002', 'OG005'], 'paramType': 'cLDA model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.251', 'ciLowerLimit': '-1.104', 'ciUpperLimit': '0.603', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.559', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.241', 'ciLowerLimit': '-1.053', 'ciUpperLimit': '0.571', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.863', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.071', 'ciLowerLimit': '-0.883', 'ciUpperLimit': '0.741', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'The number of nights per week (between consecutive visits) that a participant awakened with asthma was based on eDiary entries and was calculated by dividing the number of nights a participant awakened with asthma (positive responses of once, more than once, awake "all night") by the total number of nights (all responses) and then multiplying by 7 (standardized to a 7-day period). The average change from baseline in number of nocturnal awakenings over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average number of nocturnal awakenings during the placebo run-in period and the post-baseline value was calculated as the average number of nocturnal awakenings over Week 6 to Week 12.', 'unitOfMeasure': 'Number of awakenings', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had nocturnal awakening data.'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.857', 'groupId': 'OG000', 'lowerLimit': '-16.13', 'upperLimit': '12.413'}, {'value': '3.850', 'groupId': 'OG001', 'lowerLimit': '-11.26', 'upperLimit': '18.960'}, {'value': '7.174', 'groupId': 'OG002', 'lowerLimit': '-8.124', 'upperLimit': '22.472'}, {'value': '2.713', 'groupId': 'OG003', 'lowerLimit': '-11.12', 'upperLimit': '16.543'}, {'value': '-4.005', 'groupId': 'OG004', 'lowerLimit': '-17.83', 'upperLimit': '9.825'}, {'value': '-2.401', 'groupId': 'OG005', 'lowerLimit': '-17.16', 'upperLimit': '12.357'}]}]}], 'analyses': [{'pValue': '0.958', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.544', 'ciLowerLimit': '-19.92', 'ciUpperLimit': '21.007', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.559', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.251', 'ciLowerLimit': '-14.81', 'ciUpperLimit': '27.307', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.374', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.575', 'ciLowerLimit': '-11.62', 'ciUpperLimit': '30.766', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.618', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.114', 'ciLowerLimit': '-15.04', 'ciUpperLimit': '25.272', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.876', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.604', 'ciLowerLimit': '-21.76', 'ciUpperLimit': '18.554', 'groupDescription': 'Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': "PEF was defined as a person's maximum speed (rate) of expiration as measured with a peak flow meter in liters per minute. Participants performed triplicate PEF measurements twice daily using a PEF meter, in the AM upon rising and in the PM immediately before study drug administration at bedtime. All three values were recorded and the average of the best morning PEF and the best evening PEF for each day (AM/PM) was determined through the e-Diary. The average change from Baseline in AM/PM PEF over the last 6 weeks of a 12-week treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average AM/PM PEF value during the placebo run-in period and the post-baseline value was calculated as the average AM/PM PEF over Week 6 to Week 12.", 'unitOfMeasure': 'Liters/minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had AM/PM PEF data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'title': 'Overall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.533', 'spread': '1.007', 'groupId': 'OG000'}, {'value': '0.256', 'spread': '0.997', 'groupId': 'OG001'}, {'value': '0.696', 'spread': '1.040', 'groupId': 'OG002'}, {'value': '0.999', 'spread': '1.255', 'groupId': 'OG003'}, {'value': '0.736', 'spread': '1.028', 'groupId': 'OG004'}, {'value': '0.458', 'spread': '1.176', 'groupId': 'OG005'}]}]}, {'title': 'Activity Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '0.96', 'spread': '1.32', 'groupId': 'OG003'}, {'value': '0.66', 'spread': '1.03', 'groupId': 'OG004'}, {'value': '0.44', 'spread': '1.18', 'groupId': 'OG005'}]}]}, {'title': 'Symptoms Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '1.02', 'spread': '1.25', 'groupId': 'OG003'}, {'value': '0.83', 'spread': '1.11', 'groupId': 'OG004'}, {'value': '0.47', 'spread': '1.29', 'groupId': 'OG005'}]}]}, {'title': 'Emotional Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '1.12', 'spread': '1.62', 'groupId': 'OG003'}, {'value': '0.70', 'spread': '1.20', 'groupId': 'OG004'}, {'value': '0.45', 'spread': '1.37', 'groupId': 'OG005'}]}]}, {'title': 'Environmental Stimuli Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '0.89', 'spread': '1.47', 'groupId': 'OG003'}, {'value': '0.70', 'spread': '1.18', 'groupId': 'OG004'}, {'value': '0.49', 'spread': '1.43', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.682', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.076', 'ciLowerLimit': '-0.288', 'ciUpperLimit': '0.440', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.807', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.047', 'ciLowerLimit': '-0.422', 'ciUpperLimit': '0.329', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.403', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.165', 'ciLowerLimit': '-0.222', 'ciUpperLimit': '0.552', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.051', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.375', 'ciLowerLimit': '-0.001', 'ciUpperLimit': '0.751', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.086', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.319', 'ciLowerLimit': '-0.045', 'ciUpperLimit': '0.683', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The changes from baseline are presented for the overall scores and the individual domain scores. Baseline was the last measurement taken prior to the first double-blind study drug. The ending values were calculated as the average AQLQ(S) Overall Score and domain scores at Week 12 of a 12-week treatment period. Statistical analyses are provided for the AQLQ(S) Overall Scores only.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had AQLQ(S) data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'title': 'Overall Score', 'categories': [{'measurements': [{'value': '48.99', 'groupId': 'OG000'}, {'value': '40.49', 'groupId': 'OG001'}, {'value': '57.22', 'groupId': 'OG002'}, {'value': '64.48', 'groupId': 'OG003'}, {'value': '64.08', 'groupId': 'OG004'}, {'value': '46.14', 'groupId': 'OG005'}]}]}, {'title': 'Activity Domain', 'categories': [{'measurements': [{'value': '47.19', 'groupId': 'OG000'}, {'value': '40.46', 'groupId': 'OG001'}, {'value': '50.00', 'groupId': 'OG002'}, {'value': '60.07', 'groupId': 'OG003'}, {'value': '52.36', 'groupId': 'OG004'}, {'value': '42.61', 'groupId': 'OG005'}]}]}, {'title': 'Symptoms Domain', 'categories': [{'measurements': [{'value': '52.59', 'groupId': 'OG000'}, {'value': '42.63', 'groupId': 'OG001'}, {'value': '59.66', 'groupId': 'OG002'}, {'value': '57.76', 'groupId': 'OG003'}, {'value': '64.08', 'groupId': 'OG004'}, {'value': '48.13', 'groupId': 'OG005'}]}]}, {'title': 'Emotional Function Domain', 'categories': [{'measurements': [{'value': '56.19', 'groupId': 'OG000'}, {'value': '31.95', 'groupId': 'OG001'}, {'value': '62.10', 'groupId': 'OG002'}, {'value': '57.76', 'groupId': 'OG003'}, {'value': '53.91', 'groupId': 'OG004'}, {'value': '49.90', 'groupId': 'OG005'}]}]}, {'title': 'Environmental Stimuli Domain', 'categories': [{'measurements': [{'value': '41.79', 'groupId': 'OG000'}, {'value': '42.60', 'groupId': 'OG001'}, {'value': '59.66', 'groupId': 'OG002'}, {'value': '59.97', 'groupId': 'OG003'}, {'value': '53.16', 'groupId': 'OG004'}, {'value': '48.13', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.7687', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '21.3', 'groupDescription': 'Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4943', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.6', 'ciLowerLimit': '-24.9', 'ciUpperLimit': '12.2', 'groupDescription': 'Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN Method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3003', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '29.6', 'groupDescription': 'Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0774', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.5', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '35.7', 'groupDescription': 'Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0555', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '35.5', 'groupDescription': 'Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The percentage of participants who experienced a ≥0.5 increase in AQLQ(S) Overall and Domain Scores at Week 12 compared to baseline was calculated using the Miettinen and Nurminen (MN) method. Statistical analyses are provide for the AQLQ(S) Overall Score response rate only.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had AQLQ(S) data at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire (ACQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.807', 'groupId': 'OG000', 'lowerLimit': '-1.088', 'upperLimit': '-0.527'}, {'value': '-0.736', 'groupId': 'OG001', 'lowerLimit': '-1.033', 'upperLimit': '-0.438'}, {'value': '-0.855', 'groupId': 'OG002', 'lowerLimit': '-1.170', 'upperLimit': '-0.541'}, {'value': '-1.066', 'groupId': 'OG003', 'lowerLimit': '-1.364', 'upperLimit': '-0.768'}, {'value': '-0.931', 'groupId': 'OG004', 'lowerLimit': '-1.215', 'upperLimit': '-0.648'}, {'value': '-0.704', 'groupId': 'OG005', 'lowerLimit': '-0.982', 'upperLimit': '-0.426'}]}]}], 'analyses': [{'pValue': '0.603', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.104', 'ciLowerLimit': '-0.495', 'ciUpperLimit': '0.288', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.875', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.032', 'ciLowerLimit': '-0.436', 'ciUpperLimit': '0.372', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.476', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.151', 'ciLowerLimit': '-0.568', 'ciUpperLimit': '0.265', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.362', 'ciLowerLimit': '-0.767', 'ciUpperLimit': '0.042', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.257', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.227', 'ciLowerLimit': '-0.621', 'ciUpperLimit': '0.166', 'groupDescription': 'Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.\n\ncLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. Change from baseline to Week 12 in ACQ was estimated using a cLDA model. In the cLDA analysis, the Baseline value was the last measurement taken prior to the first double-blind study drug and the post-baseline value was calculated as the average ACQ Score at Week 12.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had ACQ data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '65.51', 'groupId': 'OG000'}, {'value': '59.57', 'groupId': 'OG001'}, {'value': '66.60', 'groupId': 'OG002'}, {'value': '71.11', 'groupId': 'OG003'}, {'value': '64.72', 'groupId': 'OG004'}, {'value': '62.43', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.742', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '21.1', 'groupDescription': 'Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7248', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-22.1', 'ciUpperLimit': '15.4', 'groupDescription': 'Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6991', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '22.6', 'groupDescription': 'Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3934', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '26.2', 'groupDescription': 'Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8032', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '20.5', 'groupDescription': 'Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).', 'statisticalMethod': 'MN method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. The percentage of participants who experienced a ≥0.5 decrease in ACQ Score at Week 12 compared to Baseline was calculated using the MN method.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had ACQ data at Week 12.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asthma Attack Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'OG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'OG002', 'title': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'OG003', 'title': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'OG004', 'title': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.482', 'groupId': 'OG000', 'lowerLimit': '-0.159', 'upperLimit': '1.122'}, {'value': '0.182', 'groupId': 'OG001', 'lowerLimit': '-0.49', 'upperLimit': '0.854'}, {'value': '0.017', 'groupId': 'OG002', 'lowerLimit': '-0.673', 'upperLimit': '0.708'}, {'value': '0.637', 'groupId': 'OG003', 'lowerLimit': '0.011', 'upperLimit': '1.262'}, {'value': '0.248', 'groupId': 'OG004', 'lowerLimit': '-0.364', 'upperLimit': '0.86'}, {'value': '0.557', 'groupId': 'OG005', 'lowerLimit': '-0.115', 'upperLimit': '1.230'}]}]}], 'analyses': [{'pValue': '0.873', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.075', 'ciLowerLimit': '-1.004', 'ciUpperLimit': '0.853', 'groupDescription': 'Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.437', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.376', 'ciLowerLimit': '-1.326', 'ciUpperLimit': '0.575', 'groupDescription': 'Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.270', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.540', 'ciLowerLimit': '-1.504', 'ciUpperLimit': '0.423', 'groupDescription': 'Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.865', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.079', 'ciLowerLimit': '-0.839', 'ciUpperLimit': '0.997', 'groupDescription': 'Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.503', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.309', 'ciLowerLimit': '-1.219', 'ciUpperLimit': '0.600', 'groupDescription': 'Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6 to Week 12', 'description': "An asthma attack was defined as asthma symptoms during the previous 24 hours requiring one or more of the following: corticosteroid use (systemic), unscheduled visit to the doctor or urgent care clinic, unscheduled visit to the emergency department or hospitalization. Information on asthma attacks was recorded throughout the study in the participant's e-Diary, and an Analysis of Variance (ANOVA) was used to calculate the average percentage of asthma attack days over Week 6 to Week 12 of a 12-week treatment period.", 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TH2-High participants who received ≥1 study drug dose and had asthma attack data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'FG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'FG002', 'title': 'MK-1029 60 mg', 'description': 'Participants receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'FG003', 'title': 'MK-1029 150 mg', 'description': 'Participants receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'FG004', 'title': 'Montelukast 10 mg', 'description': 'Participants receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Participants receive Placebo tablets QD for 12 weeks'}, {'id': 'FG006', 'title': 'MK-1029 1 mg or 3 mg', 'description': 'Participants were to receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD. No participants were enrolled in this arm.'}, {'id': 'FG007', 'title': 'Montelukast 10 mg + MK-1029', 'description': 'Participants were to receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD. No participants were enrolled in this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '142'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '134'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Treated Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '126'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '106'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '94'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '40'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Out of 576 randomized participants, 557 received treatment. The planned MK-1029 1 or 3 mg arm and the Montelukast + MK-1029 arm did not enroll any participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}, {'value': '576', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks'}, {'id': 'BG001', 'title': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks'}, {'id': 'BG002', 'title': 'MK-1029 60 mg', 'description': 'Participants receive MK-1029 two 30 mg tablets QD for 12 weeks'}, {'id': 'BG003', 'title': 'MK-1029 150 mg', 'description': 'Participants receive MK-1029 150 mg tablets QD for 12 weeks'}, {'id': 'BG004', 'title': 'Montelukast 10 mg', 'description': 'Participants receive Montelukast 10 mg tablets QD for 12 weeks'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Participants receive Placebo tablets QD for 12 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}, {'value': '576', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '39.9', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '43', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '41.7', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '43.7', 'spread': '13.3', 'groupId': 'BG004'}, {'value': '41.1', 'spread': '12.4', 'groupId': 'BG005'}, {'value': '42.5', 'spread': '12.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}, {'value': '576', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '298', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '87', 'groupId': 'BG005'}, {'value': '278', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Asthma Phenotype', 'classes': [{'title': 'Th2-High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '126', 'groupId': 'BG005'}, {'value': '557', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '325', 'groupId': 'BG006'}]}]}, {'title': 'Th2-Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}, {'value': '576', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}, {'value': '232', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'The Asthma Phenotype in this study was defined as either "Th2-High" or "Th2-Low," based on measurements of asthmatic inflammation. Th2-High was defined according to the following 2 criteria at Visit 1: a peripheral-blood absolute eosinophil count ≥ 0.30 X 10\\^9/liters(L), and/or a peripheral-blood absolute eosinophil count ≥0.14 X 10\\^9/L with serum total IgE ≥100 IU/mL. Th2-Low was operationally defined as meeting neither of these criteria.', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants who received ≥1 dose of study drug.'}], 'populationDescription': 'All Randomized Participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 576}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2012-07-03', 'resultsFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-15', 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'FEV1 is the amount of air (in liters) forcibly exhaled in one second. Repeated measurements of FEV1 were collected at visits during the 12 week active treatment period and the average change from baseline in FEV1 over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a constrained longitudinal data analysis (cLDA) model. In the cLDA analysis, baseline was the average FEV1 during the placebo run-in period and the post-baseline value was the average FEV1 over Week 6 to Week 12.'}, {'measure': 'Percentage of Participants Who Experience Adverse Events (AEs)', 'timeFrame': 'Up to 14 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.'}, {'measure': 'Percentage of Participants Who Discontinue Study Due to AEs', 'timeFrame': 'Up to 14 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Asthma Exacerbation Days', 'timeFrame': 'Week 6 to Week 12', 'description': 'An asthma exacerbation day was defined as a day with ANY of the following: a decrease from Baseline in morning (AM) Peak Expiratory Flow (PEF) of more than 20%, an AM PEF of less than 180 liters (L)/min, an increase in Short Acting Beta2 Agonist (SABA) use of more than 70% (and a minimum increase of at least 2 puffs), an increase from Baseline in Daytime Asthma Symptom Score of more than 50%, an overnight asthma symptom of: Awake "all night", or an asthma attack. Information on asthma exacerbation days was recorded throughout the study in the participant\'s electronic diary (e-Diary), and an Analysis of Variance (ANOVA) was used to calculate the average percentage of days with asthma exacerbations over Week 6 to Week 12.'}, {'measure': 'Average Change From Baseline in Daytime Symptom Score (DSS)', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'The Daytime Symptom Score assessed daytime asthma symptoms. In the evening just before going to bed, participants scored their asthma symptoms for the period since arising by answering the following 4 questions in eDiaries: 1) How often did you experience asthma symptoms today?, 2) How much did your asthma symptoms bother you?, 3) How much activity could you do today? and 4) How often did your asthma affect your activities today? The 4 questions were scored on a 7-point scale (0=best to 6=worst) and averaged for a single score. The average change from baseline in DSS over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average DSS score during the placebo run-in period and the post-baseline value was the average DSS Score over Week 6 to Week 12.'}, {'measure': 'Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'Twice daily (upon arising and before going to sleep), participants recorded the total number of puff (actuations) of SABA used for asthma symptoms in their eDiaries. The number of SABA puffs used in one day was calculated based on eDiary entries as the sum of daytime and nighttime number of puffs of SABA. The average change from baseline over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) in the daily number of SABA puffs was estimated using a cLDA model. In the cLDA analysis, Baseline was the average number of SABA puffs used in one day during the placebo run-in period and the post-baseline value was calculated as the average number of SABA puffs used in one day over Week 6 to Week 12.'}, {'measure': 'Average Change From Baseline in Number of Nocturnal Awakenings', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': 'The number of nights per week (between consecutive visits) that a participant awakened with asthma was based on eDiary entries and was calculated by dividing the number of nights a participant awakened with asthma (positive responses of once, more than once, awake "all night") by the total number of nights (all responses) and then multiplying by 7 (standardized to a 7-day period). The average change from baseline in number of nocturnal awakenings over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average number of nocturnal awakenings during the placebo run-in period and the post-baseline value was calculated as the average number of nocturnal awakenings over Week 6 to Week 12.'}, {'measure': 'Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)', 'timeFrame': 'Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)', 'description': "PEF was defined as a person's maximum speed (rate) of expiration as measured with a peak flow meter in liters per minute. Participants performed triplicate PEF measurements twice daily using a PEF meter, in the AM upon rising and in the PM immediately before study drug administration at bedtime. All three values were recorded and the average of the best morning PEF and the best evening PEF for each day (AM/PM) was determined through the e-Diary. The average change from Baseline in AM/PM PEF over the last 6 weeks of a 12-week treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average AM/PM PEF value during the placebo run-in period and the post-baseline value was calculated as the average AM/PM PEF over Week 6 to Week 12."}, {'measure': 'Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores', 'timeFrame': 'Baseline and Week 12', 'description': 'The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The changes from baseline are presented for the overall scores and the individual domain scores. Baseline was the last measurement taken prior to the first double-blind study drug. The ending values were calculated as the average AQLQ(S) Overall Score and domain scores at Week 12 of a 12-week treatment period. Statistical analyses are provided for the AQLQ(S) Overall Scores only.'}, {'measure': 'Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores', 'timeFrame': 'Baseline and Week 12', 'description': 'The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The percentage of participants who experienced a ≥0.5 increase in AQLQ(S) Overall and Domain Scores at Week 12 compared to baseline was calculated using the Miettinen and Nurminen (MN) method. Statistical analyses are provide for the AQLQ(S) Overall Score response rate only.'}, {'measure': 'Change From Baseline in Asthma Control Questionnaire (ACQ) Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. Change from baseline to Week 12 in ACQ was estimated using a cLDA model. In the cLDA analysis, the Baseline value was the last measurement taken prior to the first double-blind study drug and the post-baseline value was calculated as the average ACQ Score at Week 12.'}, {'measure': 'Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. The percentage of participants who experienced a ≥0.5 decrease in ACQ Score at Week 12 compared to Baseline was calculated using the MN method.'}, {'measure': 'Percentage of Asthma Attack Days', 'timeFrame': 'Week 6 to Week 12', 'description': "An asthma attack was defined as asthma symptoms during the previous 24 hours requiring one or more of the following: corticosteroid use (systemic), unscheduled visit to the doctor or urgent care clinic, unscheduled visit to the emergency department or hospitalization. Information on asthma attacks was recorded throughout the study in the participant's e-Diary, and an Analysis of Variance (ANOVA) was used to calculate the average percentage of asthma attack days over Week 6 to Week 12 of a 12-week treatment period."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second \\[FEV1\\]). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; and (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12 weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in the average change from baseline in FEV1 over the last 6 weeks of the 12-week active-treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not pregnant or breastfeeding, and not planning to become pregnant during the study\n* history of symptoms of persistent asthma for at least one year\n* current use of acceptable asthma treatments and willingness to taper or discontinue these treatments; acceptable asthma treatments:\n\n * use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use of asthma controller medications; OR\n * use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone, or in combination with either a long-acting beta-agonist (LABA) or other asthma controller medications (including leukotriene receptor antagonists) and can tolerate tapering or discontinuation\n* no history of smoking OR no smoking within \\<1 year with a smoking history of ≤10 pack-years\n* ability to maintain a constant day/night, awake/sleep cycle\n* agreement to not change habitual consumption of beverages or food containing caffeine throughout the study\n* Body Mass Index (BMI) of 15 to 40 kg/m\\^2\n\nExclusion Criteria:\n\n* myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within past ≤3 months\n* hospitalization within past ≤4 weeks\n* major surgical procedure within past ≤4 weeks\n* participation in a clinical study involving an investigational drug within past ≤4 weeks\n* current regular use or recent (within past ≤5 years) past abuse of alcohol (\\>14 drinks/week) or illicit drugs\n* donation of a unit of blood within past ≤2 weeks or intention to donate a unit of blood during the study\n* evidence of another clinically significant, active pulmonary disorder such as chronic obstructive pulmonary disease (COPD)\n* emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma within past ≤8 weeks\n* respiratory tract infection requiring antibiotic treatment within past ≤8 weeks\n* evidence of active, clinically significant sinus disease within past ≤1 week\n* history of a clinically significant psychiatric disorder, other than stable depression, within past ≤12 weeks\n* history of HIV\n* hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their ingredients, including lactose and galactose\n* clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems\n* current cancer or history (within past ≤5 years) of cancer (except for successfully treated basal and squamous cell carcinomas of the skin); if cancer-free for \\>5 years, study participation may be allowed\n* evidence of uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT01656395', 'briefTitle': 'A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects With Persistent Asthma', 'orgStudyIdInfo': {'id': '1029-012'}, 'secondaryIdInfos': [{'id': '2012-000643-27', 'type': 'EUDRACT_NUMBER'}, {'id': '132230', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-1029 10 mg', 'description': 'Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks', 'interventionNames': ['Drug: MK-1029']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1029 30 mg', 'description': 'Participants receive MK-1029 30 mg tablets QD for 12 weeks', 'interventionNames': ['Drug: MK-1029']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1029 60 mg', 'description': 'Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks', 'interventionNames': ['Drug: MK-1029']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1029 150 mg', 'description': 'Participants will receive MK-1029 150 mg tablets QD for 12 weeks', 'interventionNames': ['Drug: MK-1029']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Montelukast 10 mg', 'description': 'Participants will receive Montelukast 10 mg tablets QD for 12 weeks', 'interventionNames': ['Drug: Montelukast 10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive Placebo tablets QD for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1029 1 mg or 3 mg', 'description': 'Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD.', 'interventionNames': ['Drug: MK-1029']}, {'type': 'EXPERIMENTAL', 'label': 'Montelukast 10 mg + MK-1029', 'description': 'Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD', 'interventionNames': ['Drug: Montelukast 10 mg']}], 'interventions': [{'name': 'MK-1029', 'type': 'DRUG', 'description': 'MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.', 'armGroupLabels': ['MK-1029 1 mg or 3 mg', 'MK-1029 10 mg', 'MK-1029 150 mg', 'MK-1029 30 mg', 'MK-1029 60 mg']}, {'name': 'Montelukast 10 mg', 'type': 'DRUG', 'otherNames': ['SINGULAIR®'], 'description': 'Parts I-II: Participants will receive Montelukast 10 mg tablets QD', 'armGroupLabels': ['Montelukast 10 mg', 'Montelukast 10 mg + MK-1029']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Parts I-II: Participants will receive Placebo tablets QD', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}