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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00375232
• Other study ID #: EMOEBA Trial
• Status: Withdrawn
• Phase: N/A
• First received: September 11, 2006
• Last updated: January 5, 2016
• Start date: October 2006

Study information

• Verified date: January 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

Intervention

Drug:
• Administration of montelukast or placebo

Locations

Country	Name	City	State
United States	National Institue Of Fitness and Sport	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective blunting of the EIB response by Spirometric measurement
Primary	Improvement in indices of ventilation and cardiopulmonary response measured on CPST