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
About this trial
This is an interventional treatment trial for Asthma
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
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
NCT ID
NCT02235428
First Posted
September 9, 2014
Last Updated
September 9, 2014
Sponsor
Boehringer Ingelheim
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
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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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