Respiratory Function TestsNCT00798564
Exercise Induced Asthma and Airway Reactivity in Athletes
An observational study of Respiratory Function Tests, run by Skane University Hospital.
Trial summary
The overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid related inflammatory response. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function Tests
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Dec 2009
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 100 elite swimmers 100 elite tennis players 100 aged matched non-atletic subjects, 30 aged-matcked healthy non-atopic controls
Who may be able to join
- Subjects aged 16-19 from Skåne.
- All should approve attendance in the study by signing an informed consent. Igf they are aged under 18, parents should also sign.
- Three groups are included
- Elite aspiring swimmers with an average training intensity of at least hours per week the last year.
Who cannot join
None listed.
About this study
Official title: Explorative Study "Exercise Induced Asthma and Airway Reactivity in Athletes"
The overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid related inflammatory response. The investigators also wish to compare indirect testing done as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise challenge.
Read the detailed description
By non-invasive tools the investigators wish to characterize type of airway reaction to various provocative stimuli in athletes doing two different sort activities, Tennis or swimming. As controls are being used sedentary age-matched controls from the same region, exposed to the same school environment. Thus we wish to:
- explore the prevalence of positive mannitol reactivity among swimmers and tennis player and how this relates to symptoms, disease history and to a sport specific exercise provocation test.
- compare the results from sport specific testing with a standardized eucapnic hyperventilation test (EHV)
- compare the overall reactivity to mannitol or EHV among swimmers and tennis players compared to aged matched controls.
- explore the role by CC16 in airway reactivity to different provocative stimuli and to see whether there is a difference between different sport activities, different test protocols and between athletes and controls.
- explore evidence of eicosanoid related inflammatory reaction in athletes and controls in relation to different provocative stimuli
The study population consists of 100 elite swimmers, 100 elite tennis players and 100 non-elite, eged matched controls. In the latter group, 30 are aged matched non-atopic non-asthmatic controls.
- Conditions
- Respiratory Function Tests
- Keywords
- Exercise, Mannitol
- Medical subject headings
- Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Function TestsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Leif Bjermer, Skane University Hospital
- Investigators
- Leif H Bjermer, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798564
- Sponsor's protocol ID
- 34797
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2008
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Study "Exercise Induced Asthma and Airway Reactivity in Athletes"
- ClinicalTrials.gov ID
- NCT00798564
- Acronym / sponsor ID
- 34797
- Conditions
- Respiratory Function Tests
- Keywords
- Exercise, Mannitol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Nov 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.
The overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid related inflammatory response. The investigators also wish to compare indirect testing done as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise challenge.
Detailed description
By non-invasive tools the investigators wish to characterize type of airway reaction to various provocative stimuli in athletes doing two different sort activities, Tennis or swimming. As controls are being used sedentary age-matched controls from the same region, exposed to the same school environment. Thus we wish to:
- explore the prevalence of positive mannitol reactivity among swimmers and tennis player and how this relates to symptoms, disease history and to a sport specific exercise provocation test.
- compare the results from sport specific testing with a standardized eucapnic hyperventilation test (EHV)
- compare the overall reactivity to mannitol or EHV among swimmers and tennis players compared to aged matched controls.
- explore the role by CC16 in airway reactivity to different provocative stimuli and to see whether there is a difference between different sport activities, different test protocols and between athletes and controls.
- explore evidence of eicosanoid related inflammatory reaction in athletes and controls in relation to different provocative stimuli
The study population consists of 100 elite swimmers, 100 elite tennis players and 100 non-elite, eged matched controls. In the latter group, 30 are aged matched non-atopic non-asthmatic controls.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 100 elite swimmers 100 elite tennis players 100 aged matched non-atletic subjects, 30 aged-matcked healthy non-atopic controls
Key inclusion criteria (4 listed)
- Subjects aged 16-19 from Skåne.
- All should approve attendance in the study by signing an informed consent. Igf they are aged under 18, parents should also sign.
- Three groups are included
- Elite aspiring swimmers with an average training intensity of at least hours per week the last year.
Key exclusion criteria (0 listed)
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.
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 18 Mar 2021.
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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.
Leif H Bjermer, MD, PhD principal investigator
Lund University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Function Tests, run by Skane University Hospital.
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 4 inclusion and 0 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 18 Mar 2021.