Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Phase III Long-term Study of Ba253BINEB in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182635
• Other study ID #: 54.561
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 10, 2014
• Start date: August 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. primary completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Ba253BINEB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Adverse Events		Up to 28 weeks	No
Primary	Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)		Baseline, up to week 28	No
Primary	Number of patients with abnormal changes from baseline in electrocardiogram (ECG)		Baseline, up to week 28	No
Primary	Number of patients wiht abnormal changes from baseline in laboratory tests		Baseline, up to week 28	No
Secondary	Change from baseline in FEV1 (Forced expiratory volume in one second)		Baseline, up to week 28	No
Secondary	Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)		Baseline, up to week 28	No
Secondary	Physician's global evaluation (overall improvement)		Up to week 28	No
Secondary	Patient's impression		Week 28	No
Secondary	Physician's global evaluation (final improvement)		Week 28	No

External Links

•   Link