The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Number of Patients with Adverse Events
Time frame: Up to 28 weeks
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
Time frame: Baseline, up to week 28
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
Time frame: Baseline, up to week 28
Number of patients wiht abnormal changes from baseline in laboratory tests
Time frame: Baseline, up to week 28
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time frame: Baseline, up to week 28
Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)
Time frame: Baseline, up to week 28
Physician's global evaluation (overall improvement)
Time frame: Up to week 28
Patient's impression
Time frame: Week 28
Physician's global evaluation (final improvement)
Time frame: Week 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.