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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Albuterol; Bromides; Ipratropium

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