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Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Primary Purpose

Exercise-Induced Bronchospasm

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of montelukast or placebo
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise-Induced Bronchospasm focused on measuring Exercise-Induced Bronchospasm, Asthma, Cardiopulmonary Stress Test, Eucapnic Voluntary Hyperventilation, Induced sputum

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • National Institue Of Fitness and Sport

Outcomes

Primary Outcome Measures

Effective blunting of the EIB response by Spirometric measurement
Improvement in indices of ventilation and cardiopulmonary response measured on CPST

Secondary Outcome Measures

Full Information

First Posted
September 11, 2006
Last Updated
January 5, 2016
Sponsor
Indiana University School of Medicine
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00375232
Brief Title
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
Official Title
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-Induced Bronchospasm
Keywords
Exercise-Induced Bronchospasm, Asthma, Cardiopulmonary Stress Test, Eucapnic Voluntary Hyperventilation, Induced sputum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Administration of montelukast or placebo
Primary Outcome Measure Information:
Title
Effective blunting of the EIB response by Spirometric measurement
Title
Improvement in indices of ventilation and cardiopulmonary response measured on CPST

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark O Farber, M.D.
Organizational Affiliation
Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institue Of Fitness and Sport
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

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