Terbutaline Concentrations in Blood and Urine

Study Overview
=================
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.

Official Title
-----------------
Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: inhaled and oral terbutaline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: asthmatics<br>10 male asthmatic subjects | Drug: inhaled and oral terbutaline<br>* 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.<br>* Other names: Tablet Bricanyl Retard 5 mg, MA no. 10954.;|
| Active Comparator: healthy<br>10 male healthy volunteers | Drug: inhaled and oral terbutaline<br>* 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.<br>* Other names: Tablet Bricanyl Retard 5 mg, MA no. 10954.;|
| Active Comparator: elite athletes with asthma<br>10 elite athletes with asthma. | Drug: inhaled and oral terbutaline<br>* 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.<br>* Other names: Tablet Bricanyl Retard 5 mg, MA no. 10954.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terbutaline concentrations in serum and urine |  | baseline, 4, 8, and 12 hours after medicine administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Doping, Beta agonist, Terbutaline, Pharmacokinetics