Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00380705
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2006-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], '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': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2005-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2006-09-22', 'studyFirstSubmitQcDate': '2006-09-22', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life measures'}], 'secondaryOutcomes': [{'measure': 'Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis'}]}, 'conditionsModule': {'conditions': ['Asthma', 'Rhinitis Allergic']}, 'descriptionModule': {'briefSummary': 'Allow physicians not familiar with anti-leukotriene based therapy to test it'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment\n* Voluntary acceptance to participate in the study\n\nExclusion Criteria:\n\n* Patients with cystic fibrosis\n* Patients with known hypersensitivity to singulair or any of its components\n* Patients with severe chronic asthma'}, 'identificationModule': {'nctId': 'NCT00380705', 'briefTitle': 'Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Quality of Life in Asthma and Rhinitis Allergic With Singulair', 'orgStudyIdInfo': {'id': '0476-365'}, 'secondaryIdInfos': [{'id': '2006_033'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}