Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00375232

Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Indiana University School of Medicine · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAdministration of montelukast or placebo

Timeline

Start date
2006-10-01
First posted
2006-09-12
Last updated
2016-01-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00375232. Inclusion in this directory is not an endorsement.