Back to resultsBa253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ba253BINEB
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
- Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable
- Patients aged >= 40 years or older
- Patients must be able to understand the patient information form
Exclusion Criteria:
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
- Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
- Patients with glaucoma
- Patients who have prostatic hypertrophy
- Patients with hypersensitivity to anticholinergic drugs
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ba253BINEB
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients with Adverse Events
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
Number of patients wiht abnormal changes from baseline in laboratory tests
Secondary Outcome Measures
Change from baseline in FEV1 (Forced expiratory volume in one second)
Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)
Physician's global evaluation (overall improvement)
Patient's impression
Physician's global evaluation (final improvement)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182635
Brief Title
Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Phase III Long-term Study of Ba253BINEB in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
March 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ba253BINEB
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ba253BINEB
Primary Outcome Measure Information:
Title
Number of Patients with Adverse Events
Time Frame
Up to 28 weeks
Title
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
Time Frame
Baseline, up to week 28
Title
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
Time Frame
Baseline, up to week 28
Title
Number of patients wiht abnormal changes from baseline in laboratory tests
Time Frame
Baseline, up to week 28
Secondary Outcome Measure Information:
Title
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time Frame
Baseline, up to week 28
Title
Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)
Time Frame
Baseline, up to week 28
Title
Physician's global evaluation (overall improvement)
Time Frame
Up to week 28
Title
Patient's impression
Time Frame
Week 28
Title
Physician's global evaluation (final improvement)
Time Frame
Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable
Patients aged >= 40 years or older
Patients must be able to understand the patient information form
Exclusion Criteria:
Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
Patients with glaucoma
Patients who have prostatic hypertrophy
Patients with hypersensitivity to anticholinergic drugs
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/54/54.561_U02-3418.pdf
Description
Related Info
Learn more about this trial
Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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