Terbutaline Concentrations in Blood and Urine

NCT ID: NCT00914797

Last Updated: 2009-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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asthmatics

10 male asthmatic subjects

Group Type ACTIVE_COMPARATOR

inhaled and oral terbutaline

Intervention Type DRUG

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.

healthy

10 male healthy volunteers

Group Type ACTIVE_COMPARATOR

inhaled and oral terbutaline

Intervention Type DRUG

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.

elite athletes with asthma

10 elite athletes with asthma.

Group Type ACTIVE_COMPARATOR

inhaled and oral terbutaline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076. Tablet Bricanyl Retard 5 mg, MA no. 10954.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hormone Laboratory, Aker University Hospital, Oslo, Norway

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Respiratory Research Unit, Bispebjerg Hospital

Principal Investigators

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Jimmi Elers, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, Respiratory Research Unit

Locations

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Bispebjerg Hospital, Respiratory Research Unit

København NV, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Jimmi Elers½, MD

Role: CONTACT

+45 35313208

Facility Contacts

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Jimmi Elers, MD

Role: primary

+45 35313208

Other Identifiers

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TER2009JE

Identifier Type: -

Identifier Source: org_study_id

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