Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation

PHASE3TerminatedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

August 23, 2021

Primary Completion Date

September 23, 2021

Study Completion Date

June 23, 2023

Conditions
Asthma in Children
Interventions
DRUG

Budesonide Formoterol Drug Combination

This combination will be used to treat the asthma exacerbation, patients will take one inhalation of budesonide/formoterol Turbuhaler® 100/6 μg every 5 minutes (Maximum 12 inhalations).

DRUG

nebulisation of terbutaline

Patients will receive 0.1 mg/kg nebulized terbutaline 5 mg/2 ml of Terbutaline dilution diluted with 2 ml normal saline delivered by an air compressor nebuliser driven by oxygen at a flow rate of 8l/min. The duration of one dose will be approximately 20 minutes and a total of 3 doses will be administered.

Trial Locations (8)

94000

CHI Créteil, Créteil

94270

CHU Bicêtre, Le Kremlin-Bicêtre

Unknown

CHU Ambroise Paré, Boulogne-Billancourt

CHU Antoine Béclère, Clamart

Centre Hospitalier Sud Francilien, Corbeil-Essonnes

Grand Hôpital de l'Est Francilien, Jossigny

CHU Lille, Lille

CHI Villeneuve-Saint-Georges, Villeneuve-Saint-Georges

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Centre Hospitalier Intercommunal Creteil

OTHER