Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Ba253MDI

Drug: Ba253BINEB

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182583

54.560

Details and patient eligibility

About

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.

Enrollment

163 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

Patients whose symptoms are stable and have at least 4 symptomatic days a week
Patients with FEV1.0/FVC of <= 70% in the screening test
Patients aged >= 40 years or older
Patients must be able to inhale the study drug via BINEB and MDI
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.

Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
Patients who are constantly administered oral steroid
Patients with glaucoma
Patients who have prostatic hypertrophy
Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
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