Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Ba253MDI
* Drug: Ba253BINEB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria Patients whose symptoms are stable and have at least 4 symptomatic days a week Patients with FEV1.0/FVC of <= 70% in the screening test Patients aged >= 40 years or older Patients must be able to inhale the study drug via BINEB and MDI Patients must be able to understand the patient information form Exclusion Criteria: Those who correspond to the following shall be excluded from the subjects of study. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult Patients who are constantly administered oral steroid Patients with glaucoma Patients who have prostatic hypertrophy Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study Women who are pregnant or who may become pregnant, or nursing women Patients who are judged by the investigator as inappropriate as the subjects of the study

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ba253BINEB<br> | Drug: Ba253BINEB<br> <br> |
| Active Comparator: Ba253MDI<br> | Drug: Ba253MDI<br> <br> * Other names: Tersigan® aerosol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COPD daily symptom scores |  | Baseline and up to 4 weeks after first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in times of cough |  | Baseline, up to 4 weeks after first drug administration | 
| Change from baseline in peak expiratory flow rate (PEFR) |  | Baseline, up to 4 weeks after first drug administration | 
| Number of Patients with Adverse Events |  | Up to 4 weeks | 
| Number of patients with significant changes in vital sings (blood pressure, pulse rate) |  | Baseline, week 4 | 
| Number of patients with abnormal changes in electrocardiogram (ECG) |  | Baseline, week 4 | 
| Number of patients with abnormal changes in laboratory values |  | Baseline, week 4 | 
| Physician's global evaluation |  | 4 weeks after first drug administration | 
| Patient's impression |  | 4 weeks after first drug administration | 
| Change from baseline in times and volume of sputum |  | Baseline, up to 4 weeks after first drug administration | 
| Change from baseline in transition of nocturnal sleep |  | Baseline, up to 4 weeks after first drug administration | 
| Change from baseline in FEV1 (Forced expiratory volume in one second) |  | Baseline, week 4 | 
| Change from baseline in FVC (Forced vital capacity) |  | Baseline, week 4 |