Elite sport and development of asthma: Airway inflammation and treatment.

• Conditions: Asthma

• Registration Number: EUCTR2005-003142-34-DK
• Lead Sponsor: Respiratory and Allergy Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Elite athletes (not control subjects).
- Age >/= 16 years, - Informed consent.
- Physician-diagnosed asthma.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- ICS within the last 4 weeks prior to visit 1.
- Respiratory tract infections within the last 2 weeks prior to visit 1.
- Pregnancy, breast feeding or planning pregnancy during the study.
- FEV1 < 1.5 L or FEV1 < 70 % of predicted.
- Subjects with a lung disease other than asthma.
- Smokers or ex-smokers with a smoking history of 10 pack years or more.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To investigate the change in inflammation in EVH-positive elite athletes treated with inhaled steroids in combination with long-acting beta-agonists (ICS/LABA) compared with placebo.<br>2. To investigate inflammatory differences in the airways of elite athletes with a positive eucapnic voluntary hyperventilation test (EVH) and control subjects with asthma.;Secondary Objective: 1. To investigate whether the bronchial response to EVH in elite athletes is associated with the inflammatory condition.<br>2. To investigate the effect of treatment on symptom score and lung function in EVH-positive elite athletes.;Primary end point(s): Reduced inflammation assessed by exhaled Nitric Oxide.