Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Not Applicable

Withdrawn

• Conditions: Exercise-Induced Bronchospasm

• Registration Number: NCT00375232
• Lead Sponsor: Indiana University School of Medicine

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Study Start: 2006-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in indices of ventilation and cardiopulmonary response measured on CPST
Effective blunting of the EIB response by Spirometric measurement

Trial Locations

Locations (1)

National Institue Of Fitness and Sport; 🇺🇸 Indianapolis, Indiana, United States