Healthy participants
Conditions
Interventions
Trade Name: Berotec
Product Name: Berotec Fenoterol
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Fenoterol
Concentration unit: mg/h milligram(s)/hour
Concentration type: equal
Concen
Sponsors
Erasmus Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The study will include: -a group of 15 healthy referent sedentary participants with a resting heart rate (HR) of > 55 bpm and systolic arterial pressure > 100 mmHg. Participants will take a beta 2 adrenergic blocker Salbutamol and placebo perfusion of 10mg/min and of 20mg/ min for 30 min and using a randomized double-blinded crossover study design. There will be a washout period of 1 week. --a group of 15 healthy referent sedentary participants with a resting heart rate (HR) of > 55 bpm and systolic arterial pressure > 100 mmHg. Participants will take a beta 2 adrenergic blocker Fenoterol of and placebo perfusion of 5mg min for 30 min and using a randomized double-blinded crossover study design. There will be a washout period of 1 week. Participants will be matched of age, gender and body mass index (BMI). Only healthy subject will participate to the study. Are the trial subjects under 18? 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: Asthmatic patients or subjects with chronic pneumopathy, arterial diseases or Raynaud syndrome, heart failure, myocarditis, pathological situation of mitral and aortic valve, obstructive hypertrophic cardiomyopathy, Wolff-Parkinsson-White syndrome, hypertension or hypotension, tachycardias, hyperthyroidism, hypersensibility to beta agonists will not participate. Great care will be ensured that the subjects do not smoke or drink coffee, tea, and other beverages containing caffeine or alcohol before the study. They will be investigated after a light breakfast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will determine if beta 2 adrenergic agonists enhance the HVR as well as the cardiorespiratory responses during exercise in healthy subjects. We will also determine whether respiratory equivalents correlate to peripheral chemosensitivity. This will strengthen our observation that the HRV, Ve/VO2 and Ve/VCO2 slopes are linked by common controlling mechanisms;Secondary Objective: These objectives will be determined by comparing the effects of salbutamol, fenoterol and placebo. Pharmacokinetic/dynamic modeling approaches indicated that fenoterol is 25 times more active that salbutamol but both drugs show similar brochopulmonary selectivities.;Primary end point(s): | — |
Countries
Belgium
Outcome results
None listed