Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) 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 efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.

• 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 whose symptoms are stable and have at least 4 symptomatic days a week

2. Patients with FEV1.0/FVC of <= 70% in the screening test

3. Patients aged >= 40 years or older

4. Patients must be able to inhale the study drug via BINEB and MDI

5. 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.

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

2. Patients who are constantly administered oral steroid

3. Patients with glaucoma

4. Patients who have prostatic hypertrophy

5. Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.

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

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

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