Blood- and urinary concentrations of inhaled salmeterol in asthmatic subjects and elite athletes with asthma.
- Conditions
- The purpose of this study is to assess the serum and urine concentrations of inhaled salmeterol and evaluate the difference in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2009-012069-70-DK
- Lead Sponsor
- Bispebjerg Hospital, Respiratory and Allergy Research Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 30
- Physician-diagnosed asthma with positive reversibility test or challenge test.
- Informed consent.
- Age between 18 - 45 years.
- Sex: male.
- Asthma classified as mild to moderate according to GINA guidelines.
- Used beta-2-agonist in minimum 12 months.
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
- Smokers or ex-smokers with a smoking history of 10 pack years or more.
- Respiratory tract infections within the last 2 weeks prior to study day.
- Subjects with other chronic diseases than asthma and/or allergy.
- Allergy towards the study medicine.
- Use of beta-2-agonist 10 days prior to study day.
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 serum and urine concentrations of salmeterol after inhalation of 100 microgram salmeterol as one dose.<br><br>2) To investigate the serum and urine concentrations of inhaled salmeterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.;Secondary Objective: ;Primary end point(s): Serum and urine concentrations of salmeterol assessed by liquid-chromatography-mass-spectrometry
- Secondary Outcome Measures
Name Time Method