Blood- and urinary concentrations of salbutamol in asthmatics and elite athletes with asthma; comparison between inhalation vs. oral administration.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000670-20-DK

Enrollment

Registered

2008-03-05

Start date

2009-05-11

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 is to assess the plasma and urine concentrations of salbutamol and evaluate the difference between inhaled og oral administration in three groups

Interventions

Trade Name: Inh. Ventoline diskos 0,2 mg Tabl. Ventoline 4 mg Pharmaceutical Form: Tablet INN or Proposed INN: salbutamol Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Physician-diagnosed asthma. - Informed consent. - Age between 18 - 45 years - Sex: male. - Used beta2 agonist in minimum 5 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) F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 visit 1 and 2. - Subjects with other chronic diseases than asthma and allergy.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To investigate the plasma and urine concentrations of salbutamol and evaluate the difference between inhaled salbutamol (0,8 mg) and orally salbutamol (8mg) in order to distinguish doping from prevention of exercise-induced asthma. 2. To investigate the plasma and urine concentrations of salbutamol and evaluate the difference between three groups; healthy men, male asthmatics, and elite sportsmen with asthma.;Secondary Objective: 1. To investigate whether the use of inhaled corticosteroids (ICS) influence the metabolisme of salbutamol in the three groups.;Primary end point(s): Plasma and urine concentrations of salbutamol assessed by liquid-chromatografi-mass-spectrometry.	—

Measure

Time frame

Main Objective: 1. To investigate the plasma and urine concentrations of salbutamol and evaluate the difference between inhaled salbutamol (0,8 mg) and orally salbutamol (8mg) in order to distinguish doping from prevention of exercise-induced asthma. 2. To investigate the plasma and urine concentrations of salbutamol and evaluate the difference between three groups; healthy men, male asthmatics, and elite sportsmen with asthma.;Secondary Objective: 1. To investigate whether the use of inhaled corticosteroids (ICS) influence the metabolisme of salbutamol in the three groups.;Primary end point(s): Plasma and urine concentrations of salbutamol assessed by liquid-chromatografi-mass-spectrometry.

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Countries

Denmark

Outcome results

None listed

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