Terbutaline Concentrations in Blood and Urine

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00914797
• Other study ID #: TER2009JE
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 4, 2009
• Last updated: June 4, 2009
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2009
• Source: Bispebjerg Hospital
• Contact: Jimmi Elers½, MD
• Phone: +45 35313208
• Email: jele0004[@]bbh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• inhaled and oral terbutaline
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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Respiratory Research Unit	Kobenhavn NV

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Hormone Laboratory, Aker University Hospital, Oslo, Norway

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Terbutaline concentrations in serum and urine		baseline, 4, 8, and 12 hours after medicine administration	No