Concentrations of Formoterol in Blood and Urine

Bispebjerg Hospital

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Drug: inhaled formoterol

Study type: Interventional

Funder types: Other

Identifiers

NCT00914654

EudraCT number 2009-012039-14

FOR2009JE

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

Healthty

Other group

Description:

10 healthy men

Treatment:

Drug: inhaled formoterol

Asthmatics

Other group

Description:

10 male asthmatic subjects

Treatment:

Drug: inhaled formoterol

Elite asthmatics

Other group

Description:

10 male elite athletes with asthma

Treatment:

Drug: inhaled formoterol