Asthma
Conditions
Keywords
Asthma, Doping, Beta agonist, Terbutaline, Pharmacokinetics
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.
Interventions
Inhalation of 2 mg terbutaline as powder as a single dosage. Oral terbutaline 10 mg as a single dosage. Inhaled: Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076. Oral: Tablet Bricanyl Retard 5 mg, MA no. 10954.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terbutaline concentrations in serum and urine | baseline, 4, 8, and 12 hours after medicine administration |
Countries
Denmark