Clinical Trial: Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Indiana University School of Medicine

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: September 11, 2006
Date Started: October 2006
Date Completion:
Last Updated: January 5, 2016
Last Verified: January 2016