Concentrations of Salmeterol in Blood and Urine

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

2011-03-31

Brief Summary

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The purpose of the study is to assess the blood and urine concentrations of inhaled salmeterol.

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Detailed Description

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The purpose of the study is to assess the serum and urine concentrations of salmeterol after inhalation of 100 microgram salmeterol in one dose.

Furthermore, to evaluate any difference in three groups: 10 healthy men, 10 male asthmatic subjects and 10 male elite athletes with asthma.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Healthy

10 healthy men

Group Type OTHER

inhaled salmeterol

Intervention Type DRUG

Inhalation of 100 micrograms salmeterol in one dose.

Asthmatics

10 male asthmatic subjects

Group Type OTHER

inhaled salmeterol

Intervention Type DRUG

Inhalation of 100 micrograms salmeterol in one dose.

Elite athletes with asthma

10 male elite athletes with asthma

Group Type OTHER

inhaled salmeterol

Intervention Type DRUG

Inhalation of 100 micrograms salmeterol in one dose.

Interventions

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inhaled salmeterol

Inhalation of 100 micrograms salmeterol in one dose.

Intervention Type DRUG

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 study day.
* Subjects with other chronic diseases than asthma and/or allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 10 days prior to study day.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes