Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Onsudil
Product Name: Onsudil
Product Code: Not Applicable
Pharmaceutical Form: Tablet
CAS Number: 59828-07-8
Other descriptive name: PROCATEROL HYDROCHLORIDE
Concentration unit: mg millig
Sponsors
Respiratory and Allergy research unit
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Sex: male - Age: 18-40 - Informed consent - No concurrent diseases (for the control group) - Verified Asthma (for both normal asthma group and athlete group.) - GINA 1-3 - used beta2-agonist for at least 12 months - Practising sport on an elite niveau (more than 10 hours a week) 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: - Smoker or former smoker with more than 10 years of smoking. - Respiratory infektion within the last 2 weeks - Other cronic ilness - used beta2-agonist within 6 days of the study - Allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetic and pharmakodynamic properties of inhaled vs oral administered procaterol in healthy young men, asthmatics and elite athletes with astma. ;Secondary Objective: None;Primary end point(s): Pharmacodynamic and Pharmacokinetic properties of Procaterol in different groups. | — |
Countries
Denmark
Outcome results
None listed