Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT00284856
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2006-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Bulgaria', 'Canada', 'Chile', 'China', 'Colombia', 'Ecuador', 'Egypt', 'Estonia', 'Finland', 'Greece', 'Hungary', 'India', 'Israel', 'Lebanon', 'Lithuania', 'Malaysia', 'Mexico', 'Peru', 'Philippines', 'Poland', 'Portugal', 'Romania', 'Russia', 'Slovenia', 'South Africa', 'South Korea', 'Spain', 'Turkey (Türkiye)', 'United Arab Emirates']}, '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,\n\nmanuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as\n\nconfidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The population for safety analyses was the All Patients as Treated (APaT) set.\n\nThe set included all randomized participants who took at least one dose of the\n\ndouble-blind study medication. One participant in the placebo group was randomized but did not take treatment. Therefore, participant was not included in the safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Montelukast', 'description': 'Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months', 'otherNumAtRisk': 347, 'otherNumAffected': 65, 'seriousNumAtRisk': 347, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Fluticasone', 'description': 'Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months', 'otherNumAtRisk': 336, 'otherNumAffected': 57, 'seriousNumAtRisk': 336, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months', 'otherNumAtRisk': 335, 'otherNumAffected': 72, 'seriousNumAtRisk': 335, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 71, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 50, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 95, 'numAffected': 57}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dermoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Salpingo-oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 347, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Asthma-control Days Over the 6-month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}, {'id': 'OG001', 'title': 'Fluticasone', 'description': 'Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '50.70', 'spread': '38.19', 'groupId': 'OG000', 'lowerLimit': '40.62', 'upperLimit': '49.33'}, {'value': '53.30', 'spread': '39.06', 'groupId': 'OG001', 'lowerLimit': '44.86', 'upperLimit': '53.53'}, {'value': '43.84', 'spread': '38.08', 'groupId': 'OG002', 'lowerLimit': '34.65', 'upperLimit': '43.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '5.92', 'ciLowerLimit': '0.28', 'ciUpperLimit': '11.56', 'estimateComment': 'Estimated Value is difference in least squares mean (montelukast - placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '10.14', 'ciLowerLimit': '4.50', 'ciUpperLimit': '15.78', 'estimateComment': 'Estimated value is difference in least squares mean (fluticasone - placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-4.22', 'ciLowerLimit': '-9.83', 'ciUpperLimit': '1.38', 'estimateComment': 'Estimated value is difference in least squares mean (montelukast - fluticasone)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of \\> than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}, {'id': 'OG001', 'title': 'Fluticasone', 'description': 'Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.82', 'spread': '1.03', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '-0.37'}, {'value': '1.78', 'spread': '0.97', 'groupId': 'OG001', 'lowerLimit': '-0.58', 'upperLimit': '-0.42'}, {'value': '1.90', 'spread': '0.94', 'groupId': 'OG002', 'lowerLimit': '-0.38', 'upperLimit': '-0.23'}]}]}, {'title': 'Average Change from Baseline During Period II', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '-0.05', 'estimateComment': 'Estimated value is difference in least squares mean (montelukast - placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '-0.10', 'estimateComment': 'Estimated value is difference in least squares mean (fluticasone - placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.15', 'estimateComment': 'Estimated value is difference in least squares mean (montelukast - fluticasone)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score \\& the mean baseline daytime symptom score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}, {'id': 'OG001', 'title': 'Fluticasone', 'description': 'Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '363.75', 'spread': '112.40', 'groupId': 'OG000'}, {'value': '354.28', 'spread': '101.64', 'groupId': 'OG001'}, {'value': '347.98', 'spread': '99.21', 'groupId': 'OG002'}]}]}, {'title': 'Average Change from Baseline During Period II', 'categories': [{'measurements': [{'value': '12.84', 'spread': '40.22', 'groupId': 'OG000'}, {'value': '19.31', 'spread': '44.85', 'groupId': 'OG001'}, {'value': '8.27', 'spread': '40.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '5.09', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '11.45', 'estimateComment': 'Estimated value is difference in least squares mean (montelukast - placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '11.21', 'ciLowerLimit': '4.85', 'ciUpperLimit': '17.58', 'estimateComment': 'Estimated value is difference in least squares mean (fluticasone - placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-6.13', 'ciLowerLimit': '-12.46', 'ciUpperLimit': '0.20', 'estimateComment': 'Estimated value is difference in least squares mean (montelukast - fluticasone)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.', 'unitOfMeasure': 'Liters/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Montelukast', 'description': 'Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}, {'id': 'FG001', 'title': 'Fluticasone', 'description': 'Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '347'}, {'groupId': 'FG001', 'numSubjects': '336'}, {'groupId': 'FG002', 'numSubjects': '336'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '286'}, {'groupId': 'FG002', 'numSubjects': '276'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Of the 1640 participants enrolled in the study, 621 participants were excluded during screening and not randomized. The remaining 1019 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}, {'value': '1019', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Montelukast', 'description': 'Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}, {'id': 'BG001', 'title': 'Fluticasone', 'description': 'Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '38.4', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '38.0', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '543', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2006-01-31', 'resultsFirstSubmitDate': '2011-04-06', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-06', 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Asthma-control Days Over the 6-month Treatment Period', 'timeFrame': '6 months', 'description': 'An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of \\> than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period', 'timeFrame': 'Baseline and 6 months', 'description': '4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score \\& the mean baseline daytime symptom score.'}, {'measure': 'Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period', 'timeFrame': 'Baseline and 6 months', 'description': 'PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '23380218', 'type': 'RESULT', 'citation': 'Price D, Popov TA, Bjermer L, Lu S, Petrovic R, Vandormael K, Mehta A, Strus JD, Polos PG, Philip G. Effect of montelukast for treatment of asthma in cigarette smokers. J Allergy Clin Immunol. 2013 Mar;131(3):763-71. doi: 10.1016/j.jaci.2012.12.673. Epub 2013 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day\n\nExclusion Criteria:\n\n* Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.'}, 'identificationModule': {'nctId': 'NCT00284856', 'briefTitle': 'Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes', 'orgStudyIdInfo': {'id': '0476-332'}, 'secondaryIdInfos': [{'id': '2005_108'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Arm 1: Montelukast', 'interventionNames': ['Drug: montelukast sodium', 'Drug: Comparator: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Arm 2: Fluticasone', 'interventionNames': ['Drug: Comparator: fluticasone', 'Drug: Comparator: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Arm 3: Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'montelukast sodium', 'type': 'DRUG', 'description': 'montelukast 10 mg tablet once daily, 6 month treatment period', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period', 'armGroupLabels': ['1', '3']}, {'name': 'Comparator: fluticasone', 'type': 'DRUG', 'description': 'fluticasone propionate 250 mcg twice daily, 6 month treatment period', 'armGroupLabels': ['2']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'montelukast 10 mg Pbo tablet once daily, 6 month treatment period', 'armGroupLabels': ['2', '3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}