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Terbutaline Concentrations in Blood and Urine

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00914797
Collaborator
Hormone Laboratory, Aker University Hospital, Oslo, Norway (Other)
30
Enrollment
1
Location
3
Arms
8
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: inhaled and oral terbutaline
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.
Study Start Date :
Jul 1, 2009
Anticipated Primary Completion Date :
Mar 1, 2010
Anticipated Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: asthmatics

10 male asthmatic subjects

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: healthy

    10 male healthy volunteers

    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: elite athletes with asthma

    10 elite athletes with 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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Terbutaline concentrations in serum and urine [baseline, 4, 8, and 12 hours after medicine administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital, Respiratory Research Unit Kobenhavn NV Denmark DK-2400

    Sponsors and Collaborators

    • Bispebjerg Hospital
    • Hormone Laboratory, Aker University Hospital, Oslo, Norway

    Investigators

    • Principal Investigator: Jimmi Elers, MD, Bispebjerg Hospital, Respiratory Research Unit

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00914797
    Other Study ID Numbers:
    • TER2009JE
    First Posted:
    Jun 5, 2009
    Last Update Posted:
    Jun 5, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Asthma
    Doping
    Beta agonist
    Terbutaline
    Pharmacokinetics
    Additional relevant MeSH terms:
    Asthma
    Terbutaline

    Study Results

    No Results Posted as of Jun 5, 2009