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

NCT ID: NCT02235428

Last Updated: 2014-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ipratropium bromide

Group Type: EXPERIMENTAL

Ipratropium bromide

Intervention Type: DRUG

Salbutamol

Intervention Type: DRUG

Salbutamol

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Salbutamol

Intervention Type: DRUG

Interventions

Ipratropium bromide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Salbutamol

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

244.2413

Identifier Type: -

Identifier Source: org_study_id