Blood- and urinary concentrations of inhaled formoterol in asthmatic subjects and elite asthletes with asthma.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012039-14-DK

Enrollment

Registered

2009-05-05

Start date

2009-05-25

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The purpose of this study i to assess the serum and urine concentrations of inhaled formoterol and evaluate the difference in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Inh. Oxis Turbohaler 9 mikrog Pharmaceutical Form: Inhalation powder INN or Proposed INN: FORMOTEROL FUMARATE CAS Number: 43229807 Concentration unit: µg microgram(s) Concentration type: e

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Physician-diagnosed asthma with positive reversibility test og 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Smokers og 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To investigate the serum and urine concentrations of formoterol after inhalation of 18 microgram formoterol as one dose. 2) To investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthty men, male asthmatic subjects and male elite athletes with asthma.;Secondary Objective: ;Primary end point(s): Serum and urine concentrations of formoterol assessed by liquid-chromatography-mass-spectrometry.	—

Measure

Time frame

Main Objective: 1) To investigate the serum and urine concentrations of formoterol after inhalation of 18 microgram formoterol as one dose. 2) To investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthty men, male asthmatic subjects and male elite athletes with asthma.;Secondary Objective: ;Primary end point(s): Serum and urine concentrations of formoterol assessed by liquid-chromatography-mass-spectrometry.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026