Exercise-Induced BronchospasmNCT00375232
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
A study of Exercise-Induced Bronchospasm, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-Induced Bronchospasm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- College level varsity athlete
- age 18yr or older
- healthy.
- Able to swallow pills
- No prior history of asthma
Who cannot join
- Younger than 18yr
- smoker
- Prior history of asthma
- Unable to swallow pills
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institue Of Fitness and Sport
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Exercise-Induced Bronchospasm
- Being tested
- Administration of montelukast or placebo
- Keywords
- Exercise-Induced Bronchospasm, Asthma, Cardiopulmonary Stress Test, Eucapnic Voluntary Hyperventilation, Induced sputum
- Medical subject headings
- Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of montelukast or placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective blunting of the EIB response by Spirometric measurement
Improvement in indices of ventilation and cardiopulmonary response measured on CPST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-Induced BronchospasmStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Mark O Farber, M.D., Principal investigator, Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375232
- Sponsor's protocol ID
- EMOEBA Trial
- Status last verified
- Jan 2016
- First submitted
- 11 Sep 2006
- Last updated
- 7 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes
- ClinicalTrials.gov ID
- NCT00375232
- Acronym / sponsor ID
- EMOEBA Trial
- Conditions
- Exercise-Induced Bronchospasm
- Keywords
- Exercise-Induced Bronchospasm, Asthma, Cardiopulmonary Stress Test, Eucapnic Voluntary Hyperventilation, Induced sputum
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2006
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- College level varsity athlete
- age 18yr or older
- healthy.
- Able to swallow pills
- No prior history of asthma
Key exclusion criteria (4 listed)
- Younger than 18yr
- smoker
- Prior history of asthma
- Unable to swallow pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of montelukast or placebo | Drug | – |
Primary outcome
Effective blunting of the EIB response by Spirometric measurement
Improvement in indices of ventilation and cardiopulmonary response measured on CPST
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Related trials for Exercise-Induced Bronchospasm
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark O Farber, M.D. principal investigator
Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Exercise-Induced Bronchospasm, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective blunting of the EIB response by Spirometric measurement. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.