Blod and urine concentrations of Procaterol in persons with asthma and elite athletes with asthma: a comparison of inhalation vs. oral administration.

• Conditions: Asthma; MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2010-023346-78-DK
• Lead Sponsor: Respiratory and Allergy research unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-06
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

- Sex: male
- Age: 18-40
- Informed consent
- No concurrent diseases (for the control group)
- Verified Asthma (for both normal asthma group and athlete group.)
- GINA 1-3
- used beta2-agonist for at least 12 months
- Practising sport on an elite niveau (more than 10 hours a week)
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

- Smoker or former smoker with more than 10 years of smoking.
- Respiratory infektion within the last 2 weeks
- Other cronic ilness
- used beta2-agonist within 6 days of the study
- Allergy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the pharmacokinetic and pharmakodynamic properties of inhaled vs oral administered procaterol in healthy young men, asthmatics and elite athletes with astma. ;Secondary Objective: None;Primary end point(s): Pharmacodynamic and Pharmacokinetic properties of Procaterol in different groups.