The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)
Time frame: After each drug administration
Changes in peak FEV1 response
Time frame: Baseline and after each drug administration
Onset of therapeutic FEV1 response
Time frame: After each drug administration
Duration of therapeutic FEV1 response
Time frame: After each drug administration
Time to peak FEV1 response
Time frame: After each drug administration
Forced Vital Capacity (FVC) AUC0-6
Time frame: After each drug administration
Changes from baseline in FEV1
Time frame: Baseline and after each drug administration
Number of patients with adverse events
Time frame: Up to 5 month after first drug administration
Peak FVC response
Time frame: After each drug administration
Changes from baseline in FVC
Time frame: Baseline and after each drug administration
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