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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
  Purpose

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 Intervention Phase
Asthma
Drug: inhaled and oral terbutaline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Terbutaline concentrations in serum and urine [ Time Frame: baseline, 4, 8, and 12 hours after medicine administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914797

Contacts
Contact: Jimmi Elers½, MD +45 35313208 jele0004@bbh.regionh.dk

Locations
Denmark
Bispebjerg Hospital, Respiratory Research Unit Not yet recruiting
Kobenhavn NV, Denmark, DK-2400
Contact: Jimmi Elers, MD    +45 35313208    jele0004@bbh.regionh.dk   
Principal Investigator: Jimmi Elers, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Investigators
Principal Investigator: Jimmi Elers, MD Bispebjerg Hospital, Respiratory Research Unit
  More Information

No publications provided

Responsible Party: Jimmi Elers, Respiratory Research Unit, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00914797     History of Changes
Other Study ID Numbers: TER2009JE
Study First Received: June 4, 2009
Last Updated: June 4, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Asthma
Doping
Beta agonist
Terbutaline
Pharmacokinetics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Terbutaline
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014