Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

NCT ID: NCT00375232

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

Conditions

Exercise-Induced Bronchospasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Administration of montelukast or placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Mark O Farber, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine

Locations

National Institue Of Fitness and Sport

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

EMOEBA Trial

Identifier Type: -

Identifier Source: org_study_id