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

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

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

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Ipratropium bromide; Drug: Salbutamol

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ipratropium bromide	Drug: Ipratropium bromide; Drug: Salbutamol
Active Comparator: Salbutamol	Drug: Placebo; Drug: Salbutamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in pulmonary resistance (Rint) between T0 and T120	Baseline, 120 minutes after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of accessory muscle recruitment on a 4-point scale	Up to 120 minutes after drug administration
Assessment of wheezing on a 4-point scale	Up to 120 minutes after drug administration
Assessment of dyspnoea on a 4-point scale	Up to 120 minutes after drug administration
Changes in respiratory rate	Up to 120 minutes after drug administration
Changes in Oxygen Saturation (ambient air)	Up to 120 minutes after drug administration
Changes in measurement of pulmonary resistance	Up to 120 minutes after drug administration
Number of patients dropped out because of lack of efficacy	Up to 120 minutes after drug administration
Number of patients with adverse events	Up to 17 days after last drug administration
Number of patients dropped out because of adverse events	Up to 17 days after last drug administration
Number of patients with clinical significant findings in blood pressure	Up to 120 minutes after drug administration
Number of patients with clinical significant findings in heart rate	Up to 120 minutes after drug administration
Hospital Admission rate	120 minutes after drug administration
Assessment of Patient Status by investigator on a 3-question list	72 hours after drug admimistration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Primary Completion (Actual): September 1, 1998

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 10, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Bromides; Ipratropium
• Other Study ID Numbers: 244.2413