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Concentrations of Formoterol in Blood and Urine

Phase 4
Conditions
Asthma
Interventions
Registration Number
NCT00914654
Lead Sponsor
Bispebjerg Hospital
Brief Summary

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

Detailed Description

The purpose of the study is to assess the serum and urine concentrations after inhalation of 18 microgram formoterol as one dose.

Furthermore to investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
30
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 allergy.
  • Allergy towards the study medicine.
  • Use of beta-2-agonist 10 days prior to study day.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Elite asthmaticsinhaled formoterol10 male elite athletes with asthma
Healthtyinhaled formoterol10 healthy men
Asthmaticsinhaled formoterol10 male asthmatic subjects
Primary Outcome Measures
NameTimeMethod
Serum and urine concentrations of formoterolbaseline, 4, 8, and 12 hours after medicine administration
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Bispebjerg Hospital, Respiratory Research Unit

🇩🇰

Kobenhavn NV, Denmark

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