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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
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

  1. Patients whose symptoms are stable and have at least 4 symptomatic days a week
  2. Patients with FEV1.0/FVC of <= 70% in the screening test
  3. Patients aged >= 40 years or older
  4. Patients must be able to inhale the study drug via BINEB and MDI
  5. 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.

  1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
  2. Patients who are constantly administered oral steroid
  3. Patients with glaucoma
  4. Patients who have prostatic hypertrophy
  5. Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
  6. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
  7. Women who are pregnant or who may become pregnant, or nursing women
  8. 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

    First Posted
    July 2, 2014
    Last Updated
    July 10, 2014
    Sponsor
    Boehringer Ingelheim
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    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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