Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes



Status:Withdrawn
Conditions:Asthma, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:October 2006

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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.

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.

Inclusion Criteria:

- College level varsity athlete

- age 18yr or older

- healthy.

- Able to swallow pills

- No prior history of asthma

Exclusion Criteria:

- Younger than 18yr

- smoker

- Prior history of asthma

- Unable to swallow pills
We found this trial at
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Indianapolis, Indiana 46202
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Indianapolis, IN
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