Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation (ASTHMAFAST)
Asthma in Children
About this trial
This is an interventional treatment trial for Asthma in Children
Eligibility Criteria
Inclusion Criteria:
- Children 8-17 years
- Children consulting to the ER with moderate asthma exacerbation (defined by the Pulmonary Score > 3 and ≤7)
- Score for the inhalation technique = 3
- French social security affiliation
Exclusion Criteria:
- Pneumonia
- Pulmonary and/or cardiac congenital malformations
- Chronic pulmonary disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, or post infectious bronchiolitis obliterans)
- Foreign body aspiration
- Neurological alteration
- Severe asthma exacerbation defined by Pulmonary Score > 7
- Cardiopulmonary failure imminent or mechanical ventilation indication
- Thyrotoxicosis, pheochromocytoma, type 2 diabetes, untreated hypokalemia, obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other serious cardiovascular disorders such as ischemic heart disease, tachyarrhythmias or severe heart failure.
- Pregnancy
- Breastfeeding woman
- Ongoing participation in RIPH1 Intervention Research
- History of intolerance to terbutaline
- Hypersensitivity to the active ingredient or any excipients of terbutaline
- Hypersensitivity (allergy) to budesonide, formoterol or any component of the product (lactose may contain milk proteins in small quantities)
- Patient with an ongoing treatment of itraconazole, ritonavir or other potent CYP3A4 inhibitor, quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAOIs), beta-blockers (including eyedrops) and tricyclic antidepressants
Sites / Locations
- CHU Ambroise Paré
- CHU Antoine Béclère
- Centre Hospitalier Sud Francilien
- CHI Créteil
- Grand Hôpital de l'Est Francilien
- CHU Bicêtre
- CHU Lille
- CHI Villeneuve-Saint-Georges
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
budesonide/formoterol Turbuhaler®
nebulisation of terbutaline
After randomization, patients in the experimental arm will receive budesonide/formoterol Turbuhaler® 100/6 μg, one inhalation every 5 minutes (Maximum 12 inhalations).
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. In case of an insufficient response, 3 additional doses will be administered for a maximum of 6 nebulisations.