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

NCT02235428 | Terminated Phase 4

• 1 other identifier: 244.2413
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 120 minutes after drug administration

Secondary Outcomes (13)

• 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

Study Arms (2)

Ipratropium bromide

EXPERIMENTAL

Drug: Ipratropium bromide; Drug: Salbutamol

Salbutamol

ACTIVE COMPARATOR

Drug: Placebo; Drug: Salbutamol

Interventions

Ipratropium bromide DRUG

Ipratropium bromide

Placebo DRUG

Salbutamol

Salbutamol DRUG

Ipratropium bromide; Salbutamol

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Ipratropium bromide received within four hours before admission
• First acute asthmatic attack
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Asthma

Interventions

Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 10, 2014
• Study Start: September 1, 1998
• Primary Completion: September 1, 1998
• Last Updated: September 10, 2014

Record last verified: 2014-09