Concentrations of Formoterol in Blood and Urine

Bispebjerg Hospital30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

inhaled formoterolDRUG

Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bispebjerg Hospital, Respiratory Research Unit

København NV, Denmark

Outcomes

Primary Outcomes

Serum and urine concentrations of formoterol

Time frame: baseline, 4, 8, and 12 hours after medicine administration

Central Contacts

Jimmi Elers, MD

CONTACT

+45 35313208 jele0004@bbh.regionh.dk

Data from ClinicalTrials.gov

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