Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Oxitropium

Criteria

Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable

2. Patients aged >= 40 years or older

3. Patients must be able to understand the patient information form

Exclusion Criteria:

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult

2. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study

3. Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone

4. Patients with glaucoma

5. Patients who have prostatic hypertrophy

6. Patients with hypersensitivity to anticholinergic drugs

7. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study

8. Women who are pregnant or who may become pregnant, or nursing women

9. Patients who are judged by the investigator as inappropriate as the subjects of the study