Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Ba253BINEB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182635

54.561

Details and patient eligibility

About

The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

Enrollment: 74 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Ba253BINEB

Experimental group

Treatment:

Drug: Ba253BINEB