Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Ba253BINEB

• Registration Number: NCT02182635
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-08
• Primary Completion: 1999-03
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ba253BINEB	Ba253BINEB	-

Primary Outcome Measures

Name	Time	Method
Number of Patients with Adverse Events	Up to 28 weeks
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)	Baseline, up to week 28
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)	Baseline, up to week 28
Number of patients wiht abnormal changes from baseline in laboratory tests	Baseline, up to week 28

Secondary Outcome Measures

Name	Time	Method
Patient's impression	Week 28
Change from baseline in FEV1 (Forced expiratory volume in one second)	Baseline, up to week 28
Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)	Baseline, up to week 28
Physician's global evaluation (overall improvement)	Up to week 28
Physician's global evaluation (final improvement)	Week 28