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A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ba253BINEB
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

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

Inclusion Criteria:

The patients with bronchial asthma and who satisfy the following criteria

  1. Patients aged >= 20 years or older
  2. Patients with mild to moderate severity
  3. Patients must be able to understand the patient information form

Exclusion Criteria:

  1. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the screening test
  2. Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone
  3. Patients with glaucoma
  4. Patients who have prostatic hypertrophy
  5. Patients with hypersensitivity to anticholinergic drugs
  6. Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test
  7. Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult
  8. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
  9. Women who are pregnant or who may become pregnant, or nursing women
  10. 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 abnormal changes in blood pressure and heart rate
    Number of patients with abnormal changes in ECG (electrocardiogram)
    Number of patients with abnormal changes in laboratory parameters

    Secondary Outcome Measures

    Change from baseline in symptom score
    Change from baseline in treatment score
    Change from baseline in asthma score
    Change from baseline in daily life score
    Change from baseline in nocturnal sleep score
    Change from baseline in Peak expiratory flow rate (PEFR)
    Physician's global evaluation (overall improvement and final overall improvement)
    Patient's impression
    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
    NCT02182661
    Brief Title
    A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
    Official Title
    A Phase III Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1998 (undefined)
    Primary Completion Date
    May 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 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
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    88 (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
    30 weeks
    Title
    Number of patients with abnormal changes in blood pressure and heart rate
    Time Frame
    Baseline, up to 28 weeks
    Title
    Number of patients with abnormal changes in ECG (electrocardiogram)
    Time Frame
    Baseline, up to 28 weeks
    Title
    Number of patients with abnormal changes in laboratory parameters
    Time Frame
    Baseline, up to 28 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline in symptom score
    Time Frame
    Baseline, up to 28 weeks
    Title
    Change from baseline in treatment score
    Time Frame
    Baseline, up to 28 weeks
    Title
    Change from baseline in asthma score
    Time Frame
    Baseline, week 28
    Title
    Change from baseline in daily life score
    Time Frame
    Baseline, up to 28 weeks
    Title
    Change from baseline in nocturnal sleep score
    Time Frame
    Baseline, up to 28 weeks
    Title
    Change from baseline in Peak expiratory flow rate (PEFR)
    Time Frame
    Baseline, up to 28 weeks
    Title
    Physician's global evaluation (overall improvement and final overall improvement)
    Time Frame
    Baseline, up to 28 weeks
    Title
    Patient's impression
    Time Frame
    Week 28
    Title
    Change from baseline in FEV1 (Forced expiratory volume in one second)
    Time Frame
    Baseline, up to 28 weeks
    Title
    Change from baseline in FVC (Forced vital capacity)
    Time Frame
    Baseline, up to 28 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients with bronchial asthma and who satisfy the following criteria Patients aged >= 20 years or older Patients with mild to moderate severity Patients must be able to understand the patient information form Exclusion Criteria: Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the screening test Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone Patients with glaucoma Patients who have prostatic hypertrophy Patients with hypersensitivity to anticholinergic drugs Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult 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/54/54.562_U02-3419.pdf
    Description
    Related Info

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    A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

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