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Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375232
Recruitment Status : Withdrawn
First Posted : September 12, 2006
Last Update Posted : January 7, 2016
Merck Sharp & Dohme Corp.
Information provided by:
Indiana University

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.

Condition or disease Intervention/treatment Phase
Exercise-Induced Bronchospasm Drug: Administration of montelukast or placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Primary Outcome Measures :
  1. Effective blunting of the EIB response by Spirometric measurement
  2. Improvement in indices of ventilation and cardiopulmonary response measured on CPST

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375232

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United States, Indiana
National Institue Of Fitness and Sport
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Merck Sharp & Dohme Corp.
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Principal Investigator: Mark O Farber, M.D. Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
Layout table for additonal information Identifier: NCT00375232    
Other Study ID Numbers: EMOEBA Trial
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Keywords provided by Indiana University:
Exercise-Induced Bronchospasm
Cardiopulmonary Stress Test
Eucapnic Voluntary Hyperventilation
Induced sputum
Additional relevant MeSH terms:
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Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action