- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375232
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
January 5, 2016 updated by: Indiana University School of Medicine
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- National Institue Of Fitness and Sport
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effective blunting of the EIB response by Spirometric measurement
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Improvement in indices of ventilation and cardiopulmonary response measured on CPST
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark O Farber, M.D., Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Registration Dates
First Submitted
September 11, 2006
First Submitted That Met QC Criteria
September 11, 2006
First Posted (Estimate)
September 12, 2006
Study Record Updates
Last Update Posted (Estimate)
January 7, 2016
Last Update Submitted That Met QC Criteria
January 5, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Bronchial Spasm
- Asthma, Exercise-Induced
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- EMOEBA Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise-Induced Bronchospasm
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Teva Branded Pharmaceutical Products R&D, Inc.CompletedExercise-induced BronchospasmUnited States
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Ohio State UniversityCompleted
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University of New MexicoWithdrawnExercise-induced BronchospasmUnited States
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SunovionCompletedExercise-induced BronchospasmUnited States
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GlaxoSmithKlineCompletedBronchospasm | Activity/Exercise Induced BronchospasmUnited States
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GlaxoSmithKlineCompletedBronchospasm | Activity/Exercise Induced BronchospasmUnited States
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University of ArizonaGlaxoSmithKlineCompletedExercise Induced Bronchospasm, AsthmaUnited States
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