Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Exercise-Induced Bronchospasm Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm
• Exercise-Induced Bronchospasm

• NCT number: NCT00375232
• Study type: Interventional
• Source: Indiana University
• Status: Withdrawn
• Phase: N/A
• Start date: October 2006