A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

Study Overview
=================
Brief Summary
-----------------
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
-----------------
A Phase III Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ba253BINEB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with bronchial asthma and who satisfy the following criteria Patients aged >= 20 years or older Patients with mild to moderate severity Patients must be able to understand the patient information form Exclusion Criteria: Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the screening test Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone Patients with glaucoma Patients who have prostatic hypertrophy Patients with hypersensitivity to anticholinergic drugs Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult 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
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | 30 weeks | 
| Number of patients with abnormal changes in blood pressure and heart rate |  | Baseline, up to 28 weeks | 
| Number of patients with abnormal changes in ECG (electrocardiogram) |  | Baseline, up to 28 weeks | 
| Number of patients with abnormal changes in laboratory parameters |  | Baseline, up to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in symptom score |  | Baseline, up to 28 weeks | 
| Change from baseline in treatment score |  | Baseline, up to 28 weeks | 
| Change from baseline in asthma score |  | Baseline, week 28 | 
| Change from baseline in daily life score |  | Baseline, up to 28 weeks | 
| Change from baseline in nocturnal sleep score |  | Baseline, up to 28 weeks | 
| Change from baseline in Peak expiratory flow rate (PEFR) |  | Baseline, up to 28 weeks | 
| Physician's global evaluation (overall improvement and final overall improvement) |  | Baseline, up to 28 weeks | 
| Patient's impression |  | Week 28 | 
| Change from baseline in FEV1 (Forced expiratory volume in one second) |  | Baseline, up to 28 weeks | 
| Change from baseline in FVC (Forced vital capacity) |  | Baseline, up to 28 weeks |