Clinical trial NCT04705727: Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation
Official title: Comparison of the Efficacy and Safety of Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Asthma Presenting at the Emergency Room for Moderate Exacerbation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma in Children
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-01-12
Enrollment: 102
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 therapeutic regimen for the management of persistent asthma. A recent systematic review supports the combined use of inhaled corticosteroids and LABA as both the controller and quick relief therapy (SMART) among patients aged 12 years. In Emergency room (ER), Meta-analysis showed that using salbutamol (or albuterol) by meter doses inhaler (MDI) with a valved holding chamber (VHC) in children with moderate-severe acute asthma exacerbation was more effective, that is, fewer hospital admissions, more clinical improvement, and had fewer adverse effects (tremor and tachycardia) than salbutamol by nebulizer. Therefore, several international guidelines recommend the use of salbutamol by MDI rather than by nebulizer for moderate-severe asthma exacerbations. In children older than 8 years old, dry-powder inhaler (DPI), a device that delivers medication to the lungs in the form of a dry powder is currently used for maintenance and reliever therapy rather than MDI. In this context, we aim to assess the use of combined inhaled corticosteroids and long-acting β-agonists (LABAs) as a quick relief therapy in children older than 8 years old presenting at the ER with moderate asthma exacerbation. Acute asthma patients who had severe exacerbation were excluded from this study (these patients receiving systematically continuous nebulized salbutamol and/or intravenous salbutamol upon their arrival)


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

Primary outcomes:
measure: Percentage of success
timeFrame: Up 30 minutes after the last administration
Secondary outcomes:
measure: Number of hospitalized patients
timeFrame: during the month following the asthma attack
measure: Time spent in ER
timeFrame: Up to discharge from the emergency room
measure: Score for the inhalation technique
timeFrame: Immediately after each inhalation procedure
measure: Score on the Asthma Control Questionnaire (ACT)
timeFrame: 1 week after randomisation
measure: Score on the Asthma Control Questionnaire (ACT)
timeFrame: 1 month after randomisation
measure: Number of medical visit
timeFrame: 1 week and 1 month following the exacerbation
measure: controlled asthma
timeFrame: 1 month following the exacerbation
measure: Adverse events
timeFrame: Up to 1 month following the exacerbation
measure: FEV1
timeFrame: 1 month
measure: Total pulmonary capacity
timeFrame: 1 month
measure: Vital capacity (VC)
timeFrame: 1 month
measure: FEV1/FVC ratio
timeFrame: 1 month
measure: Pulmonary score
timeFrame: Within 5 minutes following each inhalation procedure
measure: Oxygen saturation
timeFrame: Within 5 minutes following each inhalation procedure
measure: Respiratory rate
timeFrame: Within 5 minutes following each inhalation procedure
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Clamart
country: France
facility: CHU Antoine Béclère
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Créteil
country: France
facility: CHI Créteil
city: Jossigny
country: France
facility: Grand Hôpital de l'Est Francilien
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Lille
country: France
facility: CHU Lille
city: Villeneuve-Saint-Georges
country: France
facility: CHI Villeneuve-Saint-Georges
Study officials:
References: