Terbutaline Concentrations in Blood and Urine
Phase 4
- Conditions
- Asthma
- Interventions
- Drug: inhaled and oral terbutaline
- Registration Number
- NCT00914797
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.
- Detailed Description
To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline.
To investigate the above mentioned in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Physician-diagnosed asthma with positive reversibility 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.
Exclusion Criteria
- Smokers or ex-smokers with a smoking history of 10 pack years or more.
- Respiratory tract infections within the last 2 weeks prior to visit 1 and 2.
- Subjects with other chronic diseases than asthma and allergy.
- Allergy towards the study medicine.
- Use of beta-2-agonist 6 days prior to study day.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description asthmatics inhaled and oral terbutaline 10 male asthmatic subjects healthy inhaled and oral terbutaline 10 male healthy volunteers elite athletes with asthma inhaled and oral terbutaline 10 elite athletes with asthma.
- Primary Outcome Measures
Name Time Method Terbutaline concentrations in serum and urine baseline, 4, 8, and 12 hours after medicine administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bispebjerg Hospital, Respiratory Research Unit
🇩🇰Kobenhavn NV, Denmark