AsthmaNCT00841425
Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study
An observational study of Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Previously the investigators have found that adolescent elite swimmers, who have been involved in competitive swimming for only a few years, have not developed respiratory symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight increase in airway responsiveness to eucapnic voluntary… Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to Jun 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants were all elite swimmers and part of the Danish National Swimming Association's talent program for young swimmers at the baseline study.
Who may be able to join
- Age 15-19 years
- Part of the Danish National Swimming Association's talent program for young swimmers at the baseline study
- Informed consent
Who cannot join
- Upper respiratory tract infection in the previous 4 weeks (visits will be postponed)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital
Copenhagen, 2400
Lars Pedersen, MD PhD, (+45) 35 31 30 69, lars.pedersen@dadlnet.dk
About this study
Previously the investigators have found that adolescent elite swimmers, who have been involved in competitive swimming for only a few years, have not developed respiratory symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight increase in airway responsiveness to eucapnic voluntary hyperpnea. In the current study, the investigators will be doing a 3-year follow-up study on the swimmers studied previously.
Read the detailed description
Even though studies suggest that elite sport can cause AHR and airway inflammation, more studies are needed to elucidate how and when AHR and airway inflammation develop; and there is a lack of follow-up studies. The present study will give us a chance to do a follow-up study to register changes in AHR and airway inflammation in athletes without any significant airway changes at baseline.
- Conditions
- Asthma
- 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 |
|---|---|---|
| Swimmers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway responsiveness to eucapnic voluntary hyperpnea and methacholine
Measured: Three years
Secondary outcomes (1)
Airway inflammation
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars Pedersen, MD PhD, Principal investigator, Respiratory and Allergy Research Unit, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841425
- Sponsor's protocol ID
- H-B-2009-012
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
Publications
Pedersen L, Lund TK, Barnes PJ, Kharitonov SA, Backer V. Airway responsiveness and inflammation in adolescent elite swimmers. J Allergy Clin Immunol. 2008 Aug;122(2):322-7, 327.e1. doi: 10.1016/j.jaci.2008.04.041. Epub 2008 Jun 12.
PubMed 18554704
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Responsiveness and Inflammation in Adolescent Elite Swimmers: a 3-Year Prospective Follow-up Study
- ClinicalTrials.gov ID
- NCT00841425
- Acronym / sponsor ID
- H-B-2009-012
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 11 Feb 2009 (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.
Previously the investigators have found that adolescent elite swimmers, who have been involved in competitive swimming for only a few years, have not developed respiratory symptoms, signs of airway inflammation or airway hyperresponsiveness exept for a slight increase in airway responsiveness to eucapnic voluntary hyperpnea. In the current study, the investigators will be doing a 3-year follow-up study on the swimmers studied previously.
Detailed description
Even though studies suggest that elite sport can cause AHR and airway inflammation, more studies are needed to elucidate how and when AHR and airway inflammation develop; and there is a lack of follow-up studies. The present study will give us a chance to do a follow-up study to register changes in AHR and airway inflammation in athletes without any significant airway changes at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swimmers | – | – |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants were all elite swimmers and part of the Danish National Swimming Association's talent program for young swimmers at the baseline study.
Key inclusion criteria (3 listed)
- Age 15-19 years
- Part of the Danish National Swimming Association's talent program for young swimmers at the baseline study
- Informed consent
Key exclusion criteria (1 listed)
- Upper respiratory tract infection in the previous 4 weeks (visits will be postponed)
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
Airway responsiveness to eucapnic voluntary hyperpnea and methacholine
Time frame: Three years
1 secondary outcome
Airway inflammation
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
- Background: PubMed 18554704Pedersen L, Lund TK, Barnes PJ, Kharitonov SA, Backer V. Airway responsiveness and inflammation in adolescent elite swimmers. J Allergy Clin Immunol. 2008 Aug;122(2):322-7, 327.e1. doi: 10.1016/j.jaci.2008.04.041. Epub 2008 Jun 12.
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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.
Lars Pedersen, MD PhD principal investigator
Respiratory and Allergy Research Unit, Bispebjerg Hospital
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 Bispebjerg Hospital at 1 site in Denmark.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Pedersen, MD PhD ((+45) 35 31 30 69, lars.pedersen@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway responsiveness to eucapnic voluntary hyperpnea and methacholine (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841425, which also lists 1 linked publication.
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 24 Feb 2009.