Terbutaline Concentrations in Blood and Urine

June 4, 2009 updated by: Bispebjerg Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kobenhavn NV, Denmark, DK-2400
        • Bispebjerg Hospital, Respiratory Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Terbutaline concentrations in serum and urine
Time Frame: baseline, 4, 8, and 12 hours after medicine administration
baseline, 4, 8, and 12 hours after medicine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Hormone Laboratory, Aker University Hospital, Oslo, Norway

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Estimate)

June 5, 2009

Last Update Submitted That Met QC Criteria

June 4, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TER2009JE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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