Status:
TERMINATED
Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborating Sponsors:
AstraZeneca
Conditions:
Asthma in Children
Eligibility:
All Genders
8-17 years
Phase:
PHASE3
Brief Summary
Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04705727
Start Date
August 23 2021
End Date
June 23 2023
Last Update
July 27 2023
Active Locations (8)
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1
CHU Ambroise Paré
Boulogne-Billancourt, France
2
CHU Antoine Béclère
Clamart, France
3
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
4
CHI Créteil
Créteil, France, 94000