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Respimat® Inhaler vs a Metered Dose Inhaler Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Berodual® Respimat®, low inspiratory flow rate
Berodual® Respimat®, medium inspiratory flow rate
Berodual® Respimat®, high inspiratory flow rate
Berodual® HFA-MDI, low inspiratory flow rate
Berodual® HFA-MDI, medium inspiratory flow rate
Berodual® HFA-MDI, high inspiratory flow rate
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

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

Inclusion Criteria:

  • All patients must have a diagnosis of COPD and must meet the following spirometric criteria:

    • Patients must have relatively stable, mild to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤70% of predicted normal and FEV1 ≤70% of forced vital capacity (FVC). Predicted normal values calculated according to evolutionary conserved chromosome segments (ECCS)
  • Male or non-pregnant/non-lactating female patients aged ≥18 years
  • All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications
  • Current or ex-smokers with a smoking history of >10 pack years

Exclusion Criteria:

  • Patients with significant diseases other than COPD will be excluded. A 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 a disease which may influence the results of the study or the patient's ability to participate in the study
  • Patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded. The enrolment of patients who have had an exacerbation within the six weeks prior to planned study entry has to be postponed.
  • Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded
  • Patients with a recent history (i.e. six months or less) of myocardial infarction
  • Patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year
  • Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy
  • Patients with known active tuberculosis
  • Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
  • Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
  • Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1
  • Patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period or lower respiratory tract infection within the last 3 months
  • Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit
  • Patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo Berodual®
  • Patients with known narrow-angle glaucoma
  • Patients who are being treated with cromolyn sodium or nedocromil sodium
  • Patients who are being treated with antihistamines (H1 receptor antagonists)
  • Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
  • Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg Depo-Provera or Noristerat contraceptives, intrauterine devices, diaphragm plus spermicide or subdermal implants eg: Norplant®)
  • Patients with, in the opinion of the investigator, a history of and/or active significant alcohol or drug abuse
  • Patients who have taken an investigational drug within four months or six half lives (whichever is the greater) prior to screening visit and/or the administration of radiolabelled dosage forms within the three months prior to the screening visit
  • Radiation exposure from clinical studies, including that from the present study and diagnostic X-rays but excluding background radiation, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years. No patient whose occupational exposure is monitored will participate in the study

Precautions: As with other anticholinergic drugs, Berodual® should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Berodual® Respimat®

    Berodual® HFA-MDI

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of dose in the whole lung
    disposition of aerosol via gamma scintigraphy

    Secondary Outcome Measures

    Percentage of dose in the central lung zone
    disposition of aerosol via gamma scintigraphy
    Percentage of dose in the intermediate lung zone
    disposition of aerosol via gamma scintigraphy
    Percentage of dose in the peripheral lung zone
    disposition of aerosol via gamma scintigraphy
    Peripheral zone/central zone deposition ratio (lung penetration index)
    disposition of aerosol via gamma scintigraphy
    Percentate of dose in oropharyngeal deposition
    disposition of aerosol via gamma scintigraphy

    Full Information

    First Posted
    June 24, 2014
    Last Updated
    July 11, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02176200
    Brief Title
    Respimat® Inhaler vs a Metered Dose Inhaler Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
    Official Title
    A Randomised Open Label, Six Way, Cross-over Scintigraphic Evaluation of the Effect of Inspiratory Flow Rate on Lung and Oropharyngeal Deposition With the Respimat® Inhaler vs a Metered Dose Inhaler (HFA-MDI) Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    December 2004 (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 compare the lung and oropharyngeal deposition of Berodual® (fenoterol hydrobromide 50μg + ipratropium bromide 20μg /1x puff) delivered via the Respimat® inhaler and the same dose of Berodual® delivered via an hydrofluoroalkane (HFA) - metered dose inhaler (2 x puffs ) in COPD patients at different inspiratory flow rates.

    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
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Berodual® Respimat®
    Arm Type
    Experimental
    Arm Title
    Berodual® HFA-MDI
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® Respimat®, low inspiratory flow rate
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® Respimat®, medium inspiratory flow rate
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® Respimat®, high inspiratory flow rate
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® HFA-MDI, low inspiratory flow rate
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® HFA-MDI, medium inspiratory flow rate
    Intervention Type
    Drug
    Intervention Name(s)
    Berodual® HFA-MDI, high inspiratory flow rate
    Primary Outcome Measure Information:
    Title
    Percentage of dose in the whole lung
    Description
    disposition of aerosol via gamma scintigraphy
    Time Frame
    immediately after dosing
    Secondary Outcome Measure Information:
    Title
    Percentage of dose in the central lung zone
    Description
    disposition of aerosol via gamma scintigraphy
    Time Frame
    immediately after dosing
    Title
    Percentage of dose in the intermediate lung zone
    Description
    disposition of aerosol via gamma scintigraphy
    Time Frame
    immediately after dosing
    Title
    Percentage of dose in the peripheral lung zone
    Description
    disposition of aerosol via gamma scintigraphy
    Time Frame
    immediately after dosing
    Title
    Peripheral zone/central zone deposition ratio (lung penetration index)
    Description
    disposition of aerosol via gamma scintigraphy
    Time Frame
    immediately after dosing
    Title
    Percentate of dose in oropharyngeal deposition
    Description
    disposition of aerosol via gamma scintigraphy
    Time Frame
    immediately after dosing

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable, mild to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤70% of predicted normal and FEV1 ≤70% of forced vital capacity (FVC). Predicted normal values calculated according to evolutionary conserved chromosome segments (ECCS) Male or non-pregnant/non-lactating female patients aged ≥18 years All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications Current or ex-smokers with a smoking history of >10 pack years Exclusion Criteria: Patients with significant diseases other than COPD will be excluded. A 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 a disease which may influence the results of the study or the patient's ability to participate in the study Patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded. The enrolment of patients who have had an exacerbation within the six weeks prior to planned study entry has to be postponed. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded Patients with a recent history (i.e. six months or less) of myocardial infarction Patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy Patients with known active tuberculosis Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1 Patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period or lower respiratory tract infection within the last 3 months Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit Patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo Berodual® Patients with known narrow-angle glaucoma Patients who are being treated with cromolyn sodium or nedocromil sodium Patients who are being treated with antihistamines (H1 receptor antagonists) Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg Depo-Provera or Noristerat contraceptives, intrauterine devices, diaphragm plus spermicide or subdermal implants eg: Norplant®) Patients with, in the opinion of the investigator, a history of and/or active significant alcohol or drug abuse Patients who have taken an investigational drug within four months or six half lives (whichever is the greater) prior to screening visit and/or the administration of radiolabelled dosage forms within the three months prior to the screening visit Radiation exposure from clinical studies, including that from the present study and diagnostic X-rays but excluding background radiation, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years. No patient whose occupational exposure is monitored will participate in the study Precautions: As with other anticholinergic drugs, Berodual® should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/215/215.1361_U05-1746.pdf
    Description
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    Respimat® Inhaler vs a Metered Dose Inhaler Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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