Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
201
Tiotropium 18 µg inhalation capsule
Tiotropium 36 µg inhalation capsule
Placebo metered dose inhaler (MDI)
Trough forced expiratory volume in one second (FEV1.0) response
Time frame: Day 1, week 2 and 4
FEV1.0 response at 1 hour after administration
Time frame: Day 1, week 2 and 4
Trough forced vital capacity (FVC) response
Time frame: Day 1, week 2 and 4
FVC response at 1 hour after administration
Time frame: Day 1, week 2 and 4
Peak expiratory flow rate (PEF)
Time frame: in the morning and at evening every day until week 4
COPD symptom scores
Time frame: until week 4
Frequency of rescue use of β2 stimulant
Time frame: until week 4
Patient's impression
Time frame: week 4
Physician's global evaluation
Time frame: week 4
Occurrence of Adverse Events
Time frame: up to 4 weeks
Change from baseline in blood pressure
Time frame: Baseline, week 4
Change from baseline in heart rate
Time frame: Baseline, week 4
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Oxitropium MDI (100 µg/puff)
Changes in ECG findings
Time frame: Baseline, week 4
Changes from baseline in laboratory values
Time frame: Baseline, week 4