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Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ipratropium bromide
Placebo
Salbutamol
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Boys or girls between 3 and 6 years old
  • Presenting to emergency departments with an acute asthmatic attack
  • Requiring nebulised bronchodilator therapy
  • Rint increased by 200 % compared to theoretical Rint
  • Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)

Exclusion Criteria:

  • Ipratropium bromide received within four hours before admission
  • First acute asthmatic attack
  • Hospital admission to intensive care with asthma within six months before inclusion
  • Hospital admission for asthma during the month prior to inclusion
  • Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy
  • Concomitant cardiac disease
  • Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma
  • Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients
  • Renal or hepatic insufficiency
  • Poorly controlled diabetes
  • Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial
  • Past history of lung surgery
  • Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis
  • Patients unable to follow with protocol or correctly undergo the evaluations
  • Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial
  • Previous participation in this trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ipratropium bromide

    Salbutamol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes from baseline in pulmonary resistance (Rint) between T0 and T120

    Secondary Outcome Measures

    Assessment of accessory muscle recruitment on a 4-point scale
    Assessment of wheezing on a 4-point scale
    Assessment of dyspnoea on a 4-point scale
    Changes in respiratory rate
    Changes in Oxygen Saturation (ambient air)
    Changes in measurement of pulmonary resistance
    Number of patients dropped out because of lack of efficacy
    Number of patients with adverse events
    Number of patients dropped out because of adverse events
    Number of patients with clinical significant findings in blood pressure
    Number of patients with clinical significant findings in heart rate
    Hospital Admission rate
    Assessment of Patient Status by investigator on a 3-question list

    Full Information

    First Posted
    September 9, 2014
    Last Updated
    September 9, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02235428
    Brief Title
    Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children
    Official Title
    Double-blind, Controlled Trial to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, for 120 Minutes, in Acute Asthmatic Attacks in Young Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    September 1998 (undefined)
    Primary Completion Date
    September 1998 (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
    To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ipratropium bromide
    Arm Type
    Experimental
    Arm Title
    Salbutamol
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Ipratropium bromide
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Salbutamol
    Primary Outcome Measure Information:
    Title
    Changes from baseline in pulmonary resistance (Rint) between T0 and T120
    Time Frame
    Baseline, 120 minutes after drug administration
    Secondary Outcome Measure Information:
    Title
    Assessment of accessory muscle recruitment on a 4-point scale
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Assessment of wheezing on a 4-point scale
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Assessment of dyspnoea on a 4-point scale
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Changes in respiratory rate
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Changes in Oxygen Saturation (ambient air)
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Changes in measurement of pulmonary resistance
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Number of patients dropped out because of lack of efficacy
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Number of patients with adverse events
    Time Frame
    Up to 17 days after last drug administration
    Title
    Number of patients dropped out because of adverse events
    Time Frame
    Up to 17 days after last drug administration
    Title
    Number of patients with clinical significant findings in blood pressure
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Number of patients with clinical significant findings in heart rate
    Time Frame
    Up to 120 minutes after drug administration
    Title
    Hospital Admission rate
    Time Frame
    120 minutes after drug administration
    Title
    Assessment of Patient Status by investigator on a 3-question list
    Time Frame
    72 hours after drug admimistration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Boys or girls between 3 and 6 years old Presenting to emergency departments with an acute asthmatic attack Requiring nebulised bronchodilator therapy Rint increased by 200 % compared to theoretical Rint Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH) Exclusion Criteria: Ipratropium bromide received within four hours before admission First acute asthmatic attack Hospital admission to intensive care with asthma within six months before inclusion Hospital admission for asthma during the month prior to inclusion Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy Concomitant cardiac disease Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients Renal or hepatic insufficiency Poorly controlled diabetes Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial Past history of lung surgery Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis Patients unable to follow with protocol or correctly undergo the evaluations Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial Previous participation in this trial

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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    Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children

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