Study to assess the safety and tolerability of COMBIVENT® hydrofluoroalkane (HFA) as compared to COMBIVENT® chlorofluorocarbons (CFC) and placebo HFA after single and repetitive dosing in healthy male and female subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Potential bronchoconstriction, objectively assessed by FEV1 and the occurence of cough, wheeze and shortness of breath
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Forced expiratory volume in one second (FEV1)
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Peak expiratory flow (PEF)
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Forced Vital Capacity (FVC)
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Mean maximal expiratory flow over the middle 50% of the FVC (MMEF25/75)
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in serum potassium levels
Time frame: Baseline, 85, 120, 155, 170 , 200, 230, 260 min after first inhalation
Occurence of adverse events
Time frame: up to 30 days
Changes in blood pressure
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in pulse rate
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in respiratory rate
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tremor measurement
Time frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in electrocardiogram (ECG), QTc interval
Time frame: Baseline, 85, 120, 155, 170, 200 min after first inhalation (230, 260, 320 min only to be performed if abnormal ECG)
Number of subjects with clinically relevant changes from baseline in physical examination
Time frame: Screening, end-of study-evaluation (within 8 days after the last treatment)
Number of subjects with clinically signification changes from baseline in laboratory values
Time frame: Screening, end-of study-evaluation (within 8 days after the last treatment)