AsthmaNCT00806000
Prevalence of Exercise-Induced Asthma in Select Cohorts of College Athletes
An observational study of Asthma, run by Ohio State University at 1 site in United States.
Trial summary
This study is investigating how commonly exercise-induced asthma happens in athletes and the best way to diagnose exercise-induced asthma. Exercise-induced asthma describes narrowing of the airways in the lungs that occurs in certain people when they exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2010
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: select athletic teams including men and women's ice hockey, soccer, and lacross
Who may be able to join
- Varsity athlete on athletic team of interest here at The Ohio State University
- 18 years of age or older
- No short-acting bronchodilator use for 6 hours prior to testing
- No long-acting bronchodilator use for 36 hours prior to testing
- No inhaled corticosteroids or leukotriene modifiers for 72 hours prior to testing
- Non-smoker for 6 months or longer
- Less than 10 pack year (number of packs per day (x) years of smoking=pack years) smoking history, as smoking causes chronic changes in the profile of inflammatory cells of lungs and also makes airways more likely to spasm. This is true even for non-smokers
Who cannot join
- pregnancy
- recent upper respiratory tract infection (within 2 weeks of study enrollment)
- Objective evidence of severe lung impairment on pulmonary testing performed at the beginning of the study.
- Participation in another interventional research trial
- Unable to provide consent
- Asthma exacerbation within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
This study is investigating how commonly exercise-induced asthma happens in athletes and the best way to diagnose exercise-induced asthma. Exercise-induced asthma describes narrowing of the airways in the lungs that occurs in certain people when they exercise. This can cause shortness of breath, cough, and fatigue during exercise and can impair athletic performance. Exercise-induced asthma can be difficult to diagnose. This is a research study, because the investigators are examining the best way to document a diagnosis of exercise-induced asthma. The investigators are also interested in examining why exercise-induced asthma may occur.
Read the detailed description
prospective, cohort study of the prevalence of asthma in select athletic teams at a large, collegiate athletic program as documented by self-report versus lung function testing. Athletes from men's and women's ice hockey, soccer, and lacrosse will be studied. Each athlete will indicate via self-report on questionnaires whether they have asthma, and then subsequently will be tested utilizing specialized lung function testing. These teams were chosen, because it will allow for gender-matching across teams and they had subjectively reported asthma prevalence rates based on prior pilot data.
Inclusion Criteria:
- Varsity athlete on athletic team of interest here at The Ohio State University
- 18 years of age or older
- No short-acting bronchodilator use for 6 hours prior to testing
- No long-acting bronchodilator use for 36 hours prior to testing
- No inhaled corticosteroids or leukotriene modifiers for 72 hours prior to testing
- Non-smoker for 6 months or longer
- Less than 10 pack year (number of packs per day (x) years of smoking=pack years) smoking history, as smoking causes chronic changes in the profile of inflammatory cells of lungs and also makes airways more likely to spasm. This is true even for non-smokers.
Exclusion criteria:
- pregnancy
- recent upper respiratory tract infection (within 2 weeks of study enrollment)
- Objective evidence of severe lung impairment on pulmonary testing performed at the beginning of the study.
- Participation in another interventional research trial
- Unable to provide consent
- Asthma exacerbation within the last 4 weeks
- Conditions
- Asthma
- Keywords
- Prevalence of Exercised induced asthma in athletes
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Athletes | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Parsons, Ohio State University
- Investigators
- Jonathan P Parsons, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806000
- Sponsor's protocol ID
- 2008H0094
- Status last verified
- Oct 2012
- First submitted
- 9 Dec 2008
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Exercise-Induced Asthma in Select Cohorts of College Athletes
- ClinicalTrials.gov ID
- NCT00806000
- Acronym / sponsor ID
- 2008H0094
- Conditions
- Asthma
- Keywords
- Prevalence of Exercised induced asthma in athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Dec 2008 (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.
This study is investigating how commonly exercise-induced asthma happens in athletes and the best way to diagnose exercise-induced asthma. Exercise-induced asthma describes narrowing of the airways in the lungs that occurs in certain people when they exercise. This can cause shortness of breath, cough, and fatigue during exercise and can impair athletic performance. Exercise-induced asthma can be difficult to diagnose. This is a research study, because the investigators are examining the best way to document a diagnosis of exercise-induced asthma. The investigators are also interested in examining why exercise-induced asthma may occur.
Detailed description
prospective, cohort study of the prevalence of asthma in select athletic teams at a large, collegiate athletic program as documented by self-report versus lung function testing. Athletes from men's and women's ice hockey, soccer, and lacrosse will be studied. Each athlete will indicate via self-report on questionnaires whether they have asthma, and then subsequently will be tested utilizing specialized lung function testing. These teams were chosen, because it will allow for gender-matching across teams and they had subjectively reported asthma prevalence rates based on prior pilot data.
Inclusion Criteria:
- Varsity athlete on athletic team of interest here at The Ohio State University
- 18 years of age or older
- No short-acting bronchodilator use for 6 hours prior to testing
- No long-acting bronchodilator use for 36 hours prior to testing
- No inhaled corticosteroids or leukotriene modifiers for 72 hours prior to testing
- Non-smoker for 6 months or longer
- Less than 10 pack year (number of packs per day (x) years of smoking=pack years) smoking history, as smoking causes chronic changes in the profile of inflammatory cells of lungs and also makes airways more likely to spasm. This is true even for non-smokers.
Exclusion criteria:
- pregnancy
- recent upper respiratory tract infection (within 2 weeks of study enrollment)
- Objective evidence of severe lung impairment on pulmonary testing performed at the beginning of the study.
- Participation in another interventional research trial
- Unable to provide consent
- Asthma exacerbation within the last 4 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- select athletic teams including men and women's ice hockey, soccer, and lacross
Key inclusion criteria (7 listed)
- Varsity athlete on athletic team of interest here at The Ohio State University
- 18 years of age or older
- No short-acting bronchodilator use for 6 hours prior to testing
- No long-acting bronchodilator use for 36 hours prior to testing
- No inhaled corticosteroids or leukotriene modifiers for 72 hours prior to testing
Key exclusion criteria (6 listed)
- pregnancy
- recent upper respiratory tract infection (within 2 weeks of study enrollment)
- Objective evidence of severe lung impairment on pulmonary testing performed at the beginning of the study.
- Participation in another interventional research trial
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
1 secondary outcome
To identify characteristics of athletes that may be associated with increased relative risk for asthma To identify characteristics of athletes that may be associated with increased relative risk for asthma. To identify characteristics of athletes tha
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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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.
Jonathan P Parsons, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Ohio State 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 10 Oct 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Oct 2012.