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

• 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 bronchial asthma and who satisfy the following criteria

1. Patients aged >= 20 years or older

2. Patients with mild to moderate severity

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

Exclusion Criteria:

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

2. Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone

3. Patients with glaucoma

4. Patients who have prostatic hypertrophy

5. Patients with hypersensitivity to anticholinergic drugs

6. Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test

7. Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult

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

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

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