The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
Change in COPD daily symptom scores
Time frame: Baseline and up to 4 weeks after first drug administration
Change from baseline in times of cough
Time frame: Baseline, up to 4 weeks after first drug administration
Change from baseline in peak expiratory flow rate (PEFR)
Time frame: Baseline, up to 4 weeks after first drug administration
Number of Patients with Adverse Events
Time frame: Up to 4 weeks
Number of patients with significant changes in vital sings (blood pressure, pulse rate)
Time frame: Baseline, week 4
Number of patients with abnormal changes in electrocardiogram (ECG)
Time frame: Baseline, week 4
Number of patients with abnormal changes in laboratory values
Time frame: Baseline, week 4
Physician's global evaluation
Time frame: 4 weeks after first drug administration
Patient's impression
Time frame: 4 weeks after first drug administration
Change from baseline in times and volume of sputum
Time frame: Baseline, up to 4 weeks after first drug administration
Change from baseline in transition of nocturnal sleep
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Time frame: Baseline, up to 4 weeks after first drug administration
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time frame: Baseline, week 4
Change from baseline in FVC (Forced vital capacity)
Time frame: Baseline, week 4