Terbutaline Concentrations in Blood and Urine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Bispebjerg Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00914797
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 4, 2009
June 4, 2009
July 2009
March 2010   (final data collection date for primary outcome measure)
Terbutaline concentrations in serum and urine [ Time Frame: baseline, 4, 8, and 12 hours after medicine administration ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Terbutaline Concentrations in Blood and Urine
Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Asthma
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.

Other Names:
  • Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076.
  • Tablet Bricanyl Retard 5 mg, MA no. 10954.
  • Active Comparator: asthmatics
    10 male asthmatic subjects
    Intervention: Drug: inhaled and oral terbutaline
  • Active Comparator: healthy
    10 male healthy volunteers
    Intervention: Drug: inhaled and oral terbutaline
  • Active Comparator: elite athletes with asthma
    10 elite athletes with asthma.
    Intervention: Drug: inhaled and oral terbutaline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact: Jimmi Elers½, MD +45 35313208 jele0004@bbh.regionh.dk
Denmark
 
NCT00914797
TER2009JE
Yes
Jimmi Elers, Respiratory Research Unit, Bispebjerg Hospital
Bispebjerg Hospital
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Principal Investigator: Jimmi Elers, MD Bispebjerg Hospital, Respiratory Research Unit
Bispebjerg Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP