Ba253BINEB 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 long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

Official Title
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A Phase III Long-term Study of Ba253BINEB in Patients With COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* 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 with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable Patients aged >= 40 years or older Patients must be able to understand the patient information form Exclusion Criteria: Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone Patients with glaucoma Patients who have prostatic hypertrophy Patients with hypersensitivity to anticholinergic drugs 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ba253BINEB<br> | Drug: Ba253BINEB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Adverse Events |  | Up to 28 weeks | 
| Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate) |  | Baseline, up to week 28 | 
| Number of patients with abnormal changes from baseline in electrocardiogram (ECG) |  | Baseline, up to week 28 | 
| Number of patients wiht abnormal changes from baseline in laboratory tests |  | Baseline, up to week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FEV1 (Forced expiratory volume in one second) |  | Baseline, up to week 28 | 
| Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep) |  | Baseline, up to week 28 | 
| Physician's global evaluation (overall improvement) |  | Up to week 28 | 
| Patient's impression |  | Week 28 | 
| Physician's global evaluation (final improvement) |  | Week 28 |