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CompletedNCT00262587Updated May 16, 2012

Elite Sport and Development of Asthma

A Phase 4 interventional study of Seretide and Placebo in Asthma, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-16.

Sponsored by Bispebjerg Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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". 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.

02

Conditions studied

  • Asthma

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Keywords

  • Sport
  • Asthma
  • Treatment
  • Airway inflammation
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 18 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Elite athletes
  • Informed consent
  • Doctor diagnosed asthma

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo inhaler (sugar powder)

    Drug: Placebo

  • Active comparator
    Seretide

    Seretide inhaler

    Drug: Seretide

Interventions

  • DrugSeretide

    Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)

  • DrugPlacebo

    Inhaled sugar powder in a placebo inhaler

06

What researchers measure

Primary outcomes

  1. Eucapnic voluntary hyperventilation (EVH)

    Time frame: End of study

  2. Exhaled Nitric Oxide

    Time frame: End of study

Secondary outcomes

  1. Respiratory symptoms

    Time frame: End of study

  2. Lung function

    Time frame: End of study

07

Study locations

1 site
  • Respiratory and Allergy Research Unit, Department of Respiratory Medicine, Bispebjerg Hospital
    Copenhagen, DK-2400 NV, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00262587
Lead sponsor
Bispebjerg Hospital
Collaborators
Imperial College London, Anti Doping Danmark, GlaxoSmithKline, The Research Foundation of Bispebjerg Hospital, Ragnhild Ibsens Legat For Medicinsk Forskning
Responsible party
Thomas Lund (MD, Bispebjerg Hospital) — Principal investigator
First posted
Dec 7, 2005
Start date
Sep 2005
Primary completion
Dec 2008
Completion
Dec 2008
Last update
May 16, 2012

Study contacts

Thomas Lund, MD
principal investigator · Respiratory and Allergy Research Unit, Department of Respiratory Medicine
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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