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

Boehringer Ingelheim

Status and phase

Terminated

Phase 4

Conditions

Asthma

Treatments

Drug: Placebo

Drug: Ipratropium bromide

Drug: Salbutamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT02235428

244.2413

Details and patient eligibility

About

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

Enrollment

3 patients

Sex

All

Ages

3 to 6 years old

Volunteers

No Healthy Volunteers

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