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Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00375232
First received: September 11, 2006
Last updated: January 5, 2016
Last verified: January 2016
  Purpose
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 Intervention
Exercise-Induced Bronchospasm
Drug: Administration of montelukast or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Resource links provided by NLM:


Further study details as provided by Indiana University:

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

Enrollment: 0
Study Start Date: October 2006
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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375232

Locations
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.
Investigators
Principal Investigator: Mark O Farber, M.D. Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
  More Information

ClinicalTrials.gov Identifier: NCT00375232     History of Changes
Other Study ID Numbers: EMOEBA Trial 
Study First Received: September 11, 2006
Last Updated: January 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Exercise-Induced Bronchospasm
Asthma
Cardiopulmonary Stress Test
Eucapnic Voluntary Hyperventilation
Induced sputum

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
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

ClinicalTrials.gov processed this record on September 28, 2016