The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary disease (COPD). The efficacy and safety profiles of the two doses administered via the RESPIMAT device will also be compared to their respective placebo groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
646
One puff, 4 times daily by oral inhalation
One puff, 4 times daily by oral inhalation
Two puffs, 4 times daily by oral inhalation
Area under the curve from 0 to 6 hours (AUC0-6) for average of forced expiratory volume in 1 second (FEV1)
Time frame: up to day 169
Peak FEV1 post treatment
Time frame: up to day 169
Onset of therapeutic FEV1 response
Time frame: up to day 169
Duration of therapeutic FEV1 response
Time frame: up to day 169
Time to peak FEV1 response
Time frame: up to day 169
Total area under the curve from 0 to 6 hours (TAUC0-6) for average FEV1 response
Time frame: up to day 169
Average change in forced vital capacity (FVC) from zero to six hours
Time frame: up to day 169
Peak FVC post treatment
Time frame: up to day 169
Peak expiratory flow rate (PEFR) measured by the patient at home two times daily
Time frame: up to day 169
Amount of inhaled rescue medication used during the treatment period
Time frame: up to day 169
Concomitant medication usage during the treatment period including steroids
Time frame: up to day 169
Change in patient daily symptom assessments
Time frame: Baseline, up to day 169
Number of patients with adverse events
Time frame: Up to day 169
Changes in vital signs (pulse rate, blood pressure)
Time frame: Baseline, up to day 169
Changes in laboratory tests
Time frame: Baseline, day 169
Number of patients with significant changes in ECG (electrocardiogram)
Time frame: Baseline, day 169
Changes in physical examination
Time frame: Baseline, day 169
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