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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Jul 2009
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 5, 2009
June 1, 2009
8 months
June 4, 2009
June 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Terbutaline concentrations in serum and urine
baseline, 4, 8, and 12 hours after medicine administration
Study Arms (3)
asthmatics
ACTIVE COMPARATOR10 male asthmatic subjects
healthy
ACTIVE COMPARATOR10 male healthy volunteers
elite athletes with asthma
ACTIVE COMPARATOR10 elite athletes with asthma.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital, Respiratory Research Unit
København NV, DK-2400, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jimmi Elers, MD
Bispebjerg Hospital, Respiratory Research Unit
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 5, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 5, 2009
Record last verified: 2009-06