Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ba253MDI
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ba253BINEB
Ba253MDI
Arm Description
Outcomes
Primary Outcome Measures
Change in COPD daily symptom scores
Secondary Outcome Measures
Change from baseline in times of cough
Change from baseline in peak expiratory flow rate (PEFR)
Number of Patients with Adverse Events
Number of patients with significant changes in vital sings (blood pressure, pulse rate)
Number of patients with abnormal changes in electrocardiogram (ECG)
Number of patients with abnormal changes in laboratory values
Physician's global evaluation
Patient's impression
Change from baseline in times and volume of sputum
Change from baseline in transition of nocturnal sleep
Change from baseline in FEV1 (Forced expiratory volume in one second)
Change from baseline in FVC (Forced vital capacity)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182583
Brief Title
Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
June 2000 (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 efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.
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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ba253BINEB
Arm Type
Experimental
Arm Title
Ba253MDI
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ba253MDI
Other Intervention Name(s)
Tersigan® aerosol
Intervention Type
Drug
Intervention Name(s)
Ba253BINEB
Primary Outcome Measure Information:
Title
Change in COPD daily symptom scores
Time Frame
Baseline and up to 4 weeks after first drug administration
Secondary Outcome Measure Information:
Title
Change from baseline in times of cough
Time Frame
Baseline, up to 4 weeks after first drug administration
Title
Change from baseline in peak expiratory flow rate (PEFR)
Time Frame
Baseline, up to 4 weeks after first drug administration
Title
Number of Patients with Adverse Events
Time Frame
Up to 4 weeks
Title
Number of patients with significant changes in vital sings (blood pressure, pulse rate)
Time Frame
Baseline, week 4
Title
Number of patients with abnormal changes in electrocardiogram (ECG)
Time Frame
Baseline, week 4
Title
Number of patients with abnormal changes in laboratory values
Time Frame
Baseline, week 4
Title
Physician's global evaluation
Time Frame
4 weeks after first drug administration
Title
Patient's impression
Time Frame
4 weeks after first drug administration
Title
Change from baseline in times and volume of sputum
Time Frame
Baseline, up to 4 weeks after first drug administration
Title
Change from baseline in transition of nocturnal sleep
Time Frame
Baseline, up to 4 weeks after first drug administration
Title
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time Frame
Baseline, week 4
Title
Change from baseline in FVC (Forced vital capacity)
Time Frame
Baseline, week 4
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 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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/54/54.560_U02-3420.pdf
Description
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Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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