Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Condition(s) targeted: Exercise-Induced Bronchospasm

Intervention: Administration of montelukast or placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Mark O Farber, M.D., Principal Investigator, Affiliation: Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine

Overall contact:
Mark O Farber, M.D., Phone: 317-988-3918, Email: mofarber@iupui.edu

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.

Official title: Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome:

Effective blunting of the EIB response by Spirometric measurement

Improvement in indices of ventilation and cardiopulmonary response measured on CPST

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Mark O Farber, M.D., Phone: 317-988-3918, Email: mofarber@iupui.edu

National Institue Of Fitness and Sport, Indianapolis, Indiana 46202, United States

Starting date: October 2006
Last updated: September 11, 2006