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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00914797
Enrollment
30
Registered
2009-06-05
Start date
2009-07-31
Completion date
2010-03-31
Last updated
2009-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Doping, Beta agonist, Terbutaline, Pharmacokinetics

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.

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.

Interventions

DRUGinhaled 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.

Sponsors

Hormone Laboratory, Aker University Hospital, Oslo, Norway
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frame
Terbutaline concentrations in serum and urinebaseline, 4, 8, and 12 hours after medicine administration

Countries

Denmark

Contacts

Primary ContactJimmi Elers½, MD
jele0004@bbh.regionh.dk+45 35313208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026