Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT00375232
Status:
WITHDRAWN
Last Update Posted:
2016-01-07
First Post:
2006-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001250', 'term': 'Asthma, Exercise-Induced'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'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'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2006-09-11', 'studyFirstSubmitQcDate': '2006-09-11', 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective blunting of the EIB response by Spirometric measurement'}, {'measure': 'Improvement in indices of ventilation and cardiopulmonary response measured on CPST'}]}, 'conditionsModule': {'keywords': ['Exercise-Induced Bronchospasm', 'Asthma', 'Cardiopulmonary Stress Test', 'Eucapnic Voluntary Hyperventilation', 'Induced sputum'], 'conditions': ['Exercise-Induced Bronchospasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.', 'detailedDescription': 'Exercise-Induced Bronchospasm (EIB) affects between 7-30% of highly trained athletes. The first phase of this study is to screen varsity level college athletes for EIB using Eucapnic hyperventilation (EVH). Those athletes who screen positive, will be enrolled in phase two, a randomized double-blinded placebo controlled double crossover study. At enrollment, athletes will undergo a cardiopulmonary stress test (CPST) and induced sputum sampling and will then be prescribed daily montelukast/placebo for a three week period. Athletes will return after three weeks and repeat the EVH, CPST, and induced sputum. They will then have a one week washout period followed by crossover once again to daily montelukast/placebo for another three weeks. After the second three weeks they will once again return for a final EVH, CPST, and induced sputum. The goal of this study is to demonstrate that effectively blunting the EIB response with montelukast, indices of ventilation,exercise tolerance, and perhaps overall physical fitness improve, allowing athletes to train more effectively, in a nonergogenic manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* College level varsity athlete\n* age 18yr or older\n* healthy.\n* Able to swallow pills\n* No prior history of asthma\n\nExclusion Criteria:\n\n* Younger than 18yr\n* smoker\n* Prior history of asthma\n* Unable to swallow pills'}, 'identificationModule': {'nctId': 'NCT00375232', 'briefTitle': 'Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes', 'orgStudyIdInfo': {'id': 'EMOEBA Trial'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of montelukast or placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'National Institue Of Fitness and Sport', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Mark O Farber, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}]}}}