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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00375232 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Exercise-Induced Bronchospasm |
Drug: Administration of montelukast or placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark O Farber, M.D. | 317-988-3918 | mofarber@iupui.edu |
| Contact: Bradley W Erickson, M.D. | 317-988-3918 | bwericks@iupui.edu |
| United States, Indiana | |
| National Institue Of Fitness and Sport | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Mark O Farber, M.D. 317-988-3918 mofarber@iupui.edu | |
| Contact: Bradley W Erickson, M.D. 317-988-3918 bwericks@iupui.edu | |
| Principal Investigator: | Mark O Farber, M.D. | Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine |
More Information
| ClinicalTrials.gov Identifier: | NCT00375232 History of Changes |
| Other Study ID Numbers: | EMOEBA Trial |
| Study First Received: | September 11, 2006 |
| Last Updated: | September 11, 2006 |
| Health Authority: | United States: Institutional Review Board |
|
Exercise-Induced Bronchospasm Asthma Cardiopulmonary Stress Test Eucapnic Voluntary Hyperventilation Induced sputum |
|
Bronchial Spasm Asthma, Exercise-Induced Bronchial Diseases Respiratory Tract Diseases Asthma Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |