Terbutaline Concentrations in Blood and Urine

Bispebjerg Hospital

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Drug: inhaled and oral terbutaline

Study type: Interventional

Funder types: Other

Identifiers

NCT00914797

TER2009JE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

asthmatics

Active Comparator group

Description:

10 male asthmatic subjects

Treatment:

Drug: inhaled and oral terbutaline

healthy

Active Comparator group

Description:

10 male healthy volunteers

Treatment:

Drug: inhaled and oral terbutaline

elite athletes with asthma

Active Comparator group

Description:

10 elite athletes with asthma.

Treatment:

Drug: inhaled and oral terbutaline