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Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

I

Indiana University School of Medicine

Status

Withdrawn

Conditions

Exercise-Induced Bronchospasm

Treatments

Drug: Administration of montelukast or placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00375232
EMOEBA Trial

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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