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Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Berodual® via Respimat®, high dose
Berodual® via Respimat®, low dose
Berodual® via MDI, high dose
Placebo Respimat®
Placebo MDI
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of bronchial asthma according to the ATS (American Thoracic Society)
  • Age: 18 - 65 years
  • Screening FEV1: 40 - 80 % of predicted normal. Predicted normal values will be based on the guidelines for standardised function testing of the European Community for Coal and Steel
  • Airway obstruction reversibility: increase in FEV1 12% from baseline and ≥ 200 ml from baseline at 30 minutes after 2 puffs of Berodual® MDI
  • Current non-smoker or ex-smoker (with a smoking history of ≤ 10 pack-years) with cessation of smoking ≥ 1 year prior to the screening visit
  • Male or female patients
  • Ability to be trained in proper use of MDI and RESPIMAT® devices
  • Ability to perform technically satisfactory pulmonary function tests
  • No hospital admission for an exacerbation and stable dosage of all pulmonary medication in the last four weeks (except for long acting β2 agonists)
  • Willingness and ability to sign informed consent form prior to participation in the trial

Exclusion Criteria:

  • Patients with significant disease other than asthma, e.g. history of clinically significant cardiovascular, renal, neurological, hepatic or endocrine dysfunction. A clinically significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or which may influence the results of the study or the ability of the patient to participate in and complete the study
  • History of myocardial infarction within the last year
  • Tuberculosis with indication for treatment
  • History of cancer within the last five years, excluding treated basal cell carcinoma
  • Patients who have undergone thoracotomy for pulmonary resection of more than one bullae, or with subsequent impaired thoracic muscle performance leading to unsatisfactory lung function testing
  • Current psychiatric disorders
  • History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
  • An upper or lower respiratory tract infection in the four weeks prior to the screening visit (= Visit 1) or during the 2-week run-in period
  • Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
  • Patients with AST/ALT (aspartate amino transferase/alanine amino transferase) (SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase)) > 200%, bilirubin > 150% (except isolated bilirubin increase due to Gilbert's Syndrome), or creatinine > 125% of the upper limit of the normal range
  • Intolerance to aerosolised fenoterol- or ipratropium-containing products, and/or hypersensitivity to any of the MDI ingredients
  • Patients using oral corticosteroid medication at unstable (i.e. less than 4 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day
  • Beta-blocker medication
  • Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit
  • History of drug abuse and/or alcoholism
  • Pregnant or nursing women and women of childbearing potential or less than 2 years postmenopausal, who are not using medically approved means of contraception (oral contraceptives, intra-uterine devices or surgical Sterilisation)
  • Previous participation in this study
  • Patients who need more than 8 puffs of salbutamol (100 µg per puff) rescue medication on 3 or more consecutive days during the run-in period
  • Severe bronchial asthma with frequent nocturnal asthma attacks or acute exacerbations induced by recurrent bronchial infections several times per year
  • Patients with known hypersensitivity to anticholinergic drugs
  • Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
  • Patients with known narrow-angle glaucoma
  • Patients who did not fill in at least 80% of the diary in the run-in period for both, medication taken and peak expiratory flow rate (PEFR) measurements are considered not compliant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Berodual® via Respimat®, high dose

    Berodual® via Respimat®, low dose

    Berodual® via MDI, high dose

    Placebo via Respimat®

    Placebo via MDI

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in average FEV1 (Forced expiratory volume in one second) (AUC0-6 (Area under the curve))

    Secondary Outcome Measures

    FEV1max
    Time to onset of therapeutic response
    Duration of therapeutic response
    Time to peak FEV1
    Change in averaged weekly morning and evening pre-dose PEFR (peak expiratory flow rate)
    Extent of use of rescue medication
    Change in night-time and daytime symptom scores
    Overall incidence of adverse events
    Number of patients with clinically significant changes in Heart rate
    Number of patients with clinically significant changes in Blood pressure
    Number of patients with clinically significant changes from baseline in laboratory investigations
    Incidence of paradoxical bronchoconstriction

    Full Information

    First Posted
    July 2, 2014
    Last Updated
    July 11, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02182479
    Brief Title
    Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients
    Official Title
    Comparison of the Safety and Efficacy of Berodual® Administered Via Respimat® Device (50 µg Fenoterol Hydrobromide/20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide/10 µg Ipratropium Bromide, 1 Puff q.i.d.) With That Administered Via the MDI (50 µg Fenoterol Hydrobromide/21 µg Ipratropium Bromide, 2 Puffs q.i.d.) in Asthma Patients Over a 12-week Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1998 (undefined)
    Primary Completion Date
    June 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
    Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at least as good in asthma patients treated for 12 weeks.

    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
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    631 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Berodual® via Respimat®, high dose
    Arm Type
    Experimental
    Arm Title
    Berodual® via Respimat®, low dose
    Arm Type
    Experimental
    Arm Title
    Berodual® via MDI, high dose
    Arm Type
    Active Comparator
    Arm Title
    Placebo via Respimat®
    Arm Type
    Placebo Comparator
    Arm Title
    Placebo via MDI
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® via Respimat®, high dose
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® via Respimat®, low dose
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® via MDI, high dose
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Respimat®
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo MDI
    Primary Outcome Measure Information:
    Title
    Change in average FEV1 (Forced expiratory volume in one second) (AUC0-6 (Area under the curve))
    Time Frame
    Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
    Secondary Outcome Measure Information:
    Title
    FEV1max
    Time Frame
    Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on day 1, 29, 57 and 85
    Title
    Time to onset of therapeutic response
    Time Frame
    Days 1, 29, 57 and 85
    Title
    Duration of therapeutic response
    Time Frame
    Days 1, 29, 57 and 85
    Title
    Time to peak FEV1
    Time Frame
    Pre-dose and 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
    Title
    Change in averaged weekly morning and evening pre-dose PEFR (peak expiratory flow rate)
    Time Frame
    up to day 85
    Title
    Extent of use of rescue medication
    Time Frame
    up to day 85
    Title
    Change in night-time and daytime symptom scores
    Time Frame
    up to day 85
    Title
    Overall incidence of adverse events
    Time Frame
    up to day 85
    Title
    Number of patients with clinically significant changes in Heart rate
    Time Frame
    Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
    Title
    Number of patients with clinically significant changes in Blood pressure
    Time Frame
    Pre-dose and 15, 30, 60, 90, 120, 180, 240, 300, 360 minutes post-dose on days 1, 29, 57 and 85
    Title
    Number of patients with clinically significant changes from baseline in laboratory investigations
    Time Frame
    Baseline and day 85
    Title
    Incidence of paradoxical bronchoconstriction
    Time Frame
    up to day 85

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of bronchial asthma according to the ATS (American Thoracic Society) Age: 18 - 65 years Screening FEV1: 40 - 80 % of predicted normal. Predicted normal values will be based on the guidelines for standardised function testing of the European Community for Coal and Steel Airway obstruction reversibility: increase in FEV1 12% from baseline and ≥ 200 ml from baseline at 30 minutes after 2 puffs of Berodual® MDI Current non-smoker or ex-smoker (with a smoking history of ≤ 10 pack-years) with cessation of smoking ≥ 1 year prior to the screening visit Male or female patients Ability to be trained in proper use of MDI and RESPIMAT® devices Ability to perform technically satisfactory pulmonary function tests No hospital admission for an exacerbation and stable dosage of all pulmonary medication in the last four weeks (except for long acting β2 agonists) Willingness and ability to sign informed consent form prior to participation in the trial Exclusion Criteria: Patients with significant disease other than asthma, e.g. history of clinically significant cardiovascular, renal, neurological, hepatic or endocrine dysfunction. A clinically significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or which may influence the results of the study or the ability of the patient to participate in and complete the study History of myocardial infarction within the last year Tuberculosis with indication for treatment History of cancer within the last five years, excluding treated basal cell carcinoma Patients who have undergone thoracotomy for pulmonary resection of more than one bullae, or with subsequent impaired thoracic muscle performance leading to unsatisfactory lung function testing Current psychiatric disorders History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis An upper or lower respiratory tract infection in the four weeks prior to the screening visit (= Visit 1) or during the 2-week run-in period Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion Patients with AST/ALT (aspartate amino transferase/alanine amino transferase) (SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase)) > 200%, bilirubin > 150% (except isolated bilirubin increase due to Gilbert's Syndrome), or creatinine > 125% of the upper limit of the normal range Intolerance to aerosolised fenoterol- or ipratropium-containing products, and/or hypersensitivity to any of the MDI ingredients Patients using oral corticosteroid medication at unstable (i.e. less than 4 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day Beta-blocker medication Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit History of drug abuse and/or alcoholism Pregnant or nursing women and women of childbearing potential or less than 2 years postmenopausal, who are not using medically approved means of contraception (oral contraceptives, intra-uterine devices or surgical Sterilisation) Previous participation in this study Patients who need more than 8 puffs of salbutamol (100 µg per puff) rescue medication on 3 or more consecutive days during the run-in period Severe bronchial asthma with frequent nocturnal asthma attacks or acute exacerbations induced by recurrent bronchial infections several times per year Patients with known hypersensitivity to anticholinergic drugs Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction Patients with known narrow-angle glaucoma Patients who did not fill in at least 80% of the diary in the run-in period for both, medication taken and peak expiratory flow rate (PEFR) measurements are considered not compliant

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/215/215.1104_U01-1083.pdf
    Description
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    Safety and Efficacy of Berodual® Respimat® Compared to Berodual® MDI (Metered Dose Inhaler) in Asthma Patients

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