Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-26 @ 5:56 PM
Study NCT ID:
NCT00127166
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Colombia', 'Croatia', 'Estonia', 'Greece', 'Italy', 'Mexico', 'Netherlands', 'Norway', 'Peru', 'Poland', 'Portugal', 'South Korea', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001250', 'term': 'Asthma, Exercise-Induced'}], 'ancestors': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D000092202', 'term': 'Exercise-Induced Allergies'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, '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': 'Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \\& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \\& 72 took M. Total of 150 pts took M and 150 took S.', 'eventGroups': [{'id': 'EG000', 'title': 'Montelukast', 'description': 'Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.\n\nPeriod II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.\n\nInhaled Fluticasone 100 mcg twice daily throughout the study.', 'otherNumAtRisk': 150, 'otherNumAffected': 27, 'seriousNumAtRisk': 150, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Salmeterol', 'description': 'Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.\n\nPeriod II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.\n\nInhaled Fluticasone 100 mcg twice daily throughout the study.', 'otherNumAtRisk': 150, 'otherNumAffected': 21, 'seriousNumAtRisk': 150, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Conjunctivitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Allergy To Plants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ear Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Menstruation Delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Post-exercise Percent (%) Fall in FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.57', 'groupId': 'OG000', 'lowerLimit': '8.86', 'upperLimit': '12.27'}, {'value': '13.82', 'groupId': 'OG001', 'lowerLimit': '12.11', 'upperLimit': '15.52'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '-3.25', 'ciLowerLimit': '-5.66', 'ciUpperLimit': '-0.84', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: participant, treatment and period. The treatment test is adjusted for period'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '116.04', 'groupId': 'OG000', 'lowerLimit': '89.95', 'upperLimit': '142.24'}, {'value': '168.75', 'groupId': 'OG001', 'lowerLimit': '142.56', 'upperLimit': '194.95'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '-52.71', 'ciLowerLimit': '-89.76', 'ciUpperLimit': '-15.66', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: participant, treatment and period. The treatment test is adjusted for period.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.', 'unitOfMeasure': 'Percent times Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.'}, {'type': 'SECONDARY', 'title': 'Maximum FEV1 % Predicted Following First Beta-agonist Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '104.03', 'groupId': 'OG000', 'lowerLimit': '102.83', 'upperLimit': '105.23'}, {'value': '99.92', 'groupId': 'OG001', 'lowerLimit': '98.72', 'upperLimit': '101.12'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '4.11', 'ciLowerLimit': '2.58', 'ciUpperLimit': '5.64', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Participant, treatment, period \\& covariate for FEV1 %-predicted Treatment test is adjusted for period \\& FEV1 %-predicted at pre-exercise baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.', 'unitOfMeasure': 'Percent of predicted value', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery to Within 5% of Baseline FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '19.12'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.065', 'upperLimit': '22.94'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.55', 'estimateComment': 'Dispersion not applicable to time to event data', 'statisticalMethod': 'Cox Proportional Hazards Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: treatment and period'}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.'}, {'type': 'SECONDARY', 'title': 'Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Montelukast', 'description': 'Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.51', 'groupId': 'OG000', 'lowerLimit': '5.44', 'upperLimit': '7.59'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '3.79'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '3.80', 'ciLowerLimit': '2.28', 'ciUpperLimit': '5.32', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model terms: participant, treatment and period. The treatment test is adjusted for period.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Montelukast / Salmeterol', 'description': 'Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 'FG001', 'title': 'Salmeterol / Montelukast', 'description': 'Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}], 'periods': [{'title': 'Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Patient did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient did not perform Visit 6 exercise', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Multicenter Study (30 Ex-US sites) Study Initiation Date: December 22, 2005 Study Completion Date: November 14, 2008', 'preAssignmentDetails': 'For randomization, patients fulfilled the following criteria:\n\n1. Forced Expiratory Volume in one second (FEV1) ≥70% predicted while withholding beta (β)-agonist for at least 6 hours\n2. Exercise-induced bronchoconstriction (EIB) showing FEV1 ≥15% reduction from baseline while on inhaled corticosteroids demonstrated twice during the run-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Montelukast / Salmeterol', 'description': 'Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 'BG001', 'title': 'Salmeterol / Montelukast', 'description': 'Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Area Under the Curve from 0 to 20 minutes (AUC0-20)', 'classes': [{'categories': [{'measurements': [{'value': '320.08', 'spread': '208.62', 'groupId': 'BG000'}, {'value': '317.74', 'spread': '165.71', 'groupId': 'BG001'}, {'value': '318.93', 'spread': '188.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Area Under the Curve for percent-change from pre-exercise baseline FEV1 in liters, from 0 to 20 minutes (AUC0-20)', 'unitOfMeasure': 'Percent times Minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Avg %-change from pre-exercise baseline FEV1 after 1st β-agonist use & prior to 2nd β-agonist use', 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'spread': '10.99', 'groupId': 'BG000'}, {'value': '4.78', 'spread': '10.92', 'groupId': 'BG001'}, {'value': '3.05', 'spread': '11.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum FEV1 percent predicted', 'classes': [{'categories': [{'measurements': [{'value': '99.88', 'spread': '32.45', 'groupId': 'BG000'}, {'value': '100.54', 'spread': '15.61', 'groupId': 'BG001'}, {'value': '100.21', 'spread': '25.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of predicted value', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum percent fall in FEV1 after exercise', 'classes': [{'categories': [{'measurements': [{'value': '24.77', 'spread': '10.25', 'groupId': 'BG000'}, {'value': '25.42', 'spread': '9.04', 'groupId': 'BG001'}, {'value': '25.09', 'spread': '9.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time to recovery', 'classes': [{'categories': [{'measurements': [{'value': '23.53', 'spread': '10.53', 'groupId': 'BG000'}, {'value': '21.51', 'spread': '8.30', 'groupId': 'BG001'}, {'value': '22.53', 'spread': '9.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Montelukast / Salmeterol, n=71; Salmeterol / Montelukast, n=70', 'unitOfMeasure': 'Minutes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2005-06-30', 'resultsFirstSubmitDate': '2009-06-16', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-29', 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Post-exercise Percent (%) Fall in FEV1', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.'}, {'measure': 'Maximum FEV1 % Predicted Following First Beta-agonist Use', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.'}, {'measure': 'Time to Recovery to Within 5% of Baseline FEV1', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.'}, {'measure': 'Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use', 'timeFrame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Exercise Induced Asthma']}, 'referencesModule': {'references': [{'pmid': '20568384', 'type': 'DERIVED', 'citation': 'Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-14 year old children with a history of asthma for at least 12 months\n* must demonstrate airway constriction brought on by exercise\n\nExclusion Criteria:\n\n* is taking any medications that are not allowed in the study'}, 'identificationModule': {'nctId': 'NCT00127166', 'briefTitle': 'Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years', 'orgStudyIdInfo': {'id': '0476-911'}, 'secondaryIdInfos': [{'id': '2004_006', 'type': 'OTHER', 'domain': 'Merck Registration Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast/Salmeterol', 'description': 'Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.', 'interventionNames': ['Drug: Montelukast sodium', 'Drug: Salmeterol xinafoate', 'Drug: Fluticasone propionate', 'Drug: Montelukast matching placebo', 'Drug: Salmeterol matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Salmeterol/Montelukast', 'description': 'Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.', 'interventionNames': ['Drug: Montelukast sodium', 'Drug: Salmeterol xinafoate', 'Drug: Fluticasone propionate', 'Drug: Montelukast matching placebo', 'Drug: Salmeterol matching placebo']}], 'interventions': [{'name': 'Montelukast sodium', 'type': 'DRUG', 'description': 'Montelukast 5 mg chewable tablet once daily', 'armGroupLabels': ['Montelukast/Salmeterol', 'Salmeterol/Montelukast']}, {'name': 'Salmeterol xinafoate', 'type': 'DRUG', 'description': 'Salmeterol 50 mcg dry powder per actuation inhaled twice daily', 'armGroupLabels': ['Montelukast/Salmeterol', 'Salmeterol/Montelukast']}, {'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': 'Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily', 'armGroupLabels': ['Montelukast/Salmeterol', 'Salmeterol/Montelukast']}, {'name': 'Montelukast matching placebo', 'type': 'DRUG', 'description': 'Matching placebo to montelukast oral tablet administered once daily.', 'armGroupLabels': ['Montelukast/Salmeterol', 'Salmeterol/Montelukast']}, {'name': 'Salmeterol matching placebo', 'type': 'DRUG', 'description': 'Matching placebo to salmeterol dry powder for inhalation administered twice daily', 'armGroupLabels': ['Montelukast/Salmeterol', 'Salmeterol/Montelukast']}]}, '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'}}}}