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Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00375232
Enrollment
0
Registered
2006-09-12
Start date
2006-10-31
Completion date
Unknown
Last updated
2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise-Induced Bronchospasm

Keywords

Exercise-Induced Bronchospasm, Asthma, Cardiopulmonary Stress Test, Eucapnic Voluntary Hyperventilation, Induced sputum

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.

Interventions

DRUGAdministration of montelukast or placebo

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Indiana University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026