AsthmaPhase 4NCT00262587
Elite Sport and Development of Asthma
A Phase 4 study testing Seretide in people with Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Seretide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to Dec 2008
- Phase
- Phase 4
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elite athletes
- Informed consent
- Doctor diagnosed asthma
Who cannot join
- Current smoker or more than 10 pack-years
- Pregnancy, breast feeding or planning pregnancy during the study.
- ICS within the last 4 weeks prior to visit 1.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital
Copenhagen, DK-2400 NV
About this study
International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". The treatment of elite athletes with asthma seems to vary widely, and only a few studies have focused on the treatment of elite athletes with asthma. Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding and better treatment of the condition. This study will investigate the type of airway inflammation in elite athletes and examine the effect of treatment with inhaled steroids in combination with long-acting beta-agonists versus placebo in the same group.
- Conditions
- Asthma
- Being tested
- Seretide, Placebo
- Keywords
- Sport, Asthma, Treatment, Airway inflammation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeretideDrug
Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)
PlaceboDrug
Inhaled sugar powder in a placebo inhaler
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo inhaler (sugar powder) Receives: Drug: Placebo |
| Seretide | Active comparator | Seretide inhaler Receives: Drug: Seretide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eucapnic voluntary hyperventilation (EVH)
Measured: End of study
Exhaled Nitric Oxide
Measured: End of study
Secondary outcomes (2)
Respiratory symptoms
Measured: End of study
Lung function
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2008
- Study completionDec 2008
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Anti Doping Danmark, GlaxoSmithKline, The Research Foundation of Bispebjerg Hospital, Ragnhild Ibsens Legat For Medicinsk Forskning
- Responsible party
- Principal investigator, Thomas Lund, Bispebjerg Hospital
- Investigators
- Thomas Lund, MD, Principal investigator, Respiratory and Allergy Research Unit, Department of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262587
- Sponsor's protocol ID
- 2005-061
- Other IDs
- (KF) 01 262958
- Status last verified
- May 2012
- First submitted
- 6 Dec 2005
- Last updated
- 16 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elite Sport and Development of Asthma
- ClinicalTrials.gov ID
- NCT00262587
- Acronym / sponsor ID
- 2005-061
- Conditions
- Asthma
- Keywords
- Sport, Asthma, Treatment, Airway inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Imperial College London, Anti Doping Danmark, GlaxoSmithKline, The Research Foundation of Bispebjerg Hospital, Ragnhild Ibsens Legat For Medicinsk Forskning
- Study start
- Sep 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Dec 2005 (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.
International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". The treatment of elite athletes with asthma seems to vary widely, and only a few studies have focused on the treatment of elite athletes with asthma. Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding and better treatment of the condition. This study will investigate the type of airway inflammation in elite athletes and examine the effect of treatment with inhaled steroids in combination with long-acting beta-agonists versus placebo in the same group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhaler (sugar powder) |
| Seretide | Active comparator | Drug: SeretideSeretide inhaler |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elite athletes
- Informed consent
- Doctor diagnosed asthma
Key exclusion criteria (3 listed)
- Current smoker or more than 10 pack-years
- Pregnancy, breast feeding or planning pregnancy during the study.
- ICS within the last 4 weeks prior to visit 1.
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 |
|---|---|---|
| SeretideCombination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr) | Drug | Seretide |
| PlaceboInhaled sugar powder in a placebo inhaler | Drug | Placebo |
Primary outcome
Eucapnic voluntary hyperventilation (EVH)
Time frame: End of study
Exhaled Nitric Oxide
Time frame: End of study
2 secondary outcomes
Respiratory symptoms
Time frame: End of study
Lung function
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 16 May 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.
Thomas Lund, MD principal investigator
Respiratory and Allergy Research Unit, Department of Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seretide in people with 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 3 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 16 May 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Eucapnic voluntary hyperventilation (EVH) (time frame: End of study). 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 16 May 2012.