Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 5:31 AM
Study NCT ID:
NCT00442559
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2007-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], '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'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic 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': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This was an open-label study. Only 53 patients had diary information with daytime asthma symptom score - thus, 138 cases were dropped from analysis due to lack of daytime asthma symptom score.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Montelukast', 'description': 'Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.', 'otherNumAtRisk': 100, 'otherNumAffected': 83, 'seriousNumAtRisk': 100, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Inhaled Corticosteroids (ICS)', 'description': "Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.", 'otherNumAtRisk': 91, 'otherNumAffected': 70, 'seriousNumAtRisk': 91, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 88, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 92, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'NASAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'PRODUCTIVE COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 36, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'SNEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'UPPER AIRWAY OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 43, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'WHEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'CHRONIC SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline for Daytime Asthma Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Daytime Asthma Symptom Score at Baseline - Montelukast', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'OG001', 'title': 'Daytime Asthma Symptom Score at 12 Weeks - Montelukast', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'OG002', 'title': 'Daytime Asthma Symptom Score at Baseline - ICS', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'OG003', 'title': 'Daytime Asthma Symptom Score at 12 Weeks - ICS', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.42', 'groupId': 'OG000', 'lowerLimit': '-0.29', 'upperLimit': '-0.03'}, {'value': '0.16', 'spread': '0.35', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '-0.02'}, {'value': '0.29', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.13', 'spread': '0.27', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '-0.03', 'groupDescription': 'Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.027', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '-0.02', 'groupDescription': 'Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included."}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Daily Allergic Rhinitis Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'OG001', 'title': 'Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'OG002', 'title': 'Daily Allergic Rhinitis Symptom Score at Baseline - ICS', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'OG003', 'title': 'Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS', 'description': 'Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '0.35', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '-0.07'}, {'value': '0.23', 'spread': '0.26', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '-0.01'}, {'value': '0.31', 'spread': '0.34', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.26', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '-0.07', 'groupDescription': 'Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.032', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '-0.01', 'groupDescription': 'Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Montelukast', 'description': 'Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'FG001', 'title': 'Inhaled Corticosteroids (ICS)', 'description': "Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': '12 Weeks After Randomization', 'achievements': [{'comment': '12 weeks after randomization was pre-specified as the time point for analysis', 'groupId': 'FG000', 'numSubjects': '68'}, {'comment': '12 weeks after randomization was pre-specified as the time point for analysis', 'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '12 weeks after randomization was pre-specified as the time point for analysis', 'groupId': 'FG000', 'numSubjects': '66'}, {'comment': '12 weeks after randomization was pre-specified as the time point for analysis', 'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Conducted at 5 sites in Korea, Jan2005\\~ Oct2007 in pediatric participants with comorbid mild asthma and allergic rhinitis. Participant's caregiver understands the study procedures and agrees to participate, signing the informed consent form.", 'preAssignmentDetails': 'Up to 1 week for wash-out - prior to baseline randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Montelukast', 'description': 'Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.'}, {'id': 'BG001', 'title': 'Inhaled Corticosteroids (ICS)', 'description': "Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.", 'unitOfMeasure': 'Participants'}, {'title': 'Allergic rhinitis', 'classes': [{'title': 'Mild-intermittent', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Mild-persistent', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Based on GINA guidelines. The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.", 'unitOfMeasure': 'participants'}, {'title': 'Type of allergic rhinitis', 'classes': [{'title': 'Seasonal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Perennial', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.", 'unitOfMeasure': 'Participants'}, {'title': 'Daily allergic rhinitis symptom score', 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '0.35', 'groupId': 'BG000'}, {'value': '0.31', 'spread': '0.34', 'groupId': 'BG001'}, {'value': '0.37', 'spread': '0.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). 24 participants with baseline scores were included in the Montelukast group and 28 participants with baseline scores were included in the ICS group.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daytime asthma symptom score', 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.42', 'groupId': 'BG000'}, {'value': '0.29', 'spread': '0.40', 'groupId': 'BG001'}, {'value': '0.30', 'spread': '0.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of allergic rhinitis', 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '1', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '24 participants were included in the Montelukast group and 28 participants were included in the ICS group.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of asthma', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.", 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2007-02-28', 'resultsFirstSubmitDate': '2008-10-12', 'studyFirstSubmitQcDate': '2007-02-28', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2008-11-10', 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline for Daytime Asthma Symptom Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline for Daily Allergic Rhinitis Symptom Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.'}]}, 'conditionsModule': {'conditions': ['Asthma', 'Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 2 and 14 years old\n* Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)\n* Diagnosed with comorbid allergic rhinitis\n\nExclusion Criteria:\n\n* Patients with suspected sinus infection\n* Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases'}, 'identificationModule': {'nctId': 'NCT00442559', 'briefTitle': 'Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis', 'orgStudyIdInfo': {'id': '0476-367'}, 'secondaryIdInfos': [{'id': '2007_003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast', 'description': 'Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.', 'interventionNames': ['Drug: montelukast sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inhaled Corticosteroids (ICS)', 'description': "Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.", 'interventionNames': ['Drug: inhaled corticosteroid']}], 'interventions': [{'name': 'montelukast sodium', 'type': 'DRUG', 'otherNames': ['Singulair, MK0476'], 'description': 'Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months', 'armGroupLabels': ['Montelukast']}, {'name': 'inhaled corticosteroid', 'type': 'DRUG', 'description': 'Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months', 'armGroupLabels': ['Inhaled Corticosteroids (ICS)']}]}, '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'}}}}