Concentrations of Salmeterol in Blood and Urine
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the blood and urine concentrations of inhaled salmeterol.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Healthy 10 healthy men |
Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
|
Other: Asthmatics 10 male asthmatic subjects |
Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
|
Other: Elite athletes with asthma 10 male elite athletes with asthma |
Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
|
Outcome Measures
Primary Outcome Measures
- Serum and urine concentrations of salmeterol [baseline, 4, 8, and 12 hours after medicine administration]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Physician-diagnosed asthma with positive reversibility or challenge test.
-
Informed consent.
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Age between 18-45 years.
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Sex: male.
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Asthma classified as mild to moderate according to GINA guidelines.
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Used beta-2-agonist in minimum 12 months.
Exclusion Criteria:
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Smokers or ex-smokers with a smoking history of 10 pack years or more.
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Respiratory tract infections within the last 2 weeks prior to study day.
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Subjects with other chronic diseases than asthma and/or allergy.
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Allergy towards the study medicine.
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Use of beta-2-agonist 10 days prior to study day.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bispebjerg Hospital, Respiratory Research Unit | Kobenhavn NV | Denmark | DK-2400 |
Sponsors and Collaborators
- Bispebjerg Hospital
- Hormone Laboratory, Aker University Hospital, Oslo, Norway
Investigators
- Principal Investigator: Jimmi Elers, MD, Bispebjerg Hospital, Respiratory Research Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAL2009JE
- EudraCT number 2009-012069-70