Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA) inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The dose response profile, safety and pharmacokinetics of Combivent HFA formulation are to be characterized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Average forced expiratory volume in the first second (FEV1) response calculated as area under the curve above test-day baseline from time 0 to 6 hours divided by six (AUC0-6h)
Time frame: 0, 1, 2, 3, 4, 5 and 6 hours post drug administration
onset of therapeutic FEV1 response
Time frame: up to 8 hours post drug administration
peak FEV1
Time frame: up to 8 hours post drug administration
time to peak FEV1
Time frame: up to 8 hours post drug administration
average of FEV1, pictured as area under the curve (AUC0-8h)
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
individual FEV1
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
individual forced vital capacity (FVC)
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
average of FVC, pictured as area under the curve (AUC0-8h)
Time frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration
peak FVC
Time frame: up to 8 hours post drug administration
ipratropium plasma concentration
Time frame: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
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albuterol plasma concentration
Time frame: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
ipratropium amount from renal excretion (Ae0-2, Ae0-8)
Time frame: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration
albuterol amount from renal excretion (Ae0-2, Ae0-8)
Time frame: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration
ipratropium plasma concentration (AUC0-8h)
Time frame: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
albuterol plasma concentration (AUC0-8h)
Time frame: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration
number of patients with Adverse Events
Time frame: up to day 49 after first drug administartion
change from baseline in pulse rate and blood pressure
Time frame: up to day 49 after first drug administartion
change from baseline in physical examination, laboratory test and 12-lead ECG
Time frame: up to day 49 after first drug administartion