Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation
- Conditions
- Asthma in Children
- Interventions
- Registration Number
- NCT04705727
- Lead Sponsor
- Centre Hospitalier Intercommunal Creteil
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nebulisation of terbutaline nebulisation of terbutaline 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. budesonide/formoterol Turbuhaler® Budesonide Formoterol Drug Combination After randomization, patients in the experimental arm will receive budesonide/formoterol Turbuhaler® 100/6 μg, one inhalation every 5 minutes (Maximum 12 inhalations).
- Primary Outcome Measures
Name Time Method Percentage of success Up 30 minutes after the last administration Percentage of success define by a pulmonary score \< 3 according to the number of administrations necessary to obtain this score.
- Secondary Outcome Measures
Name Time Method Score for the inhalation technique Immediately after each inhalation procedure Score for the inhalation technique at each procedure from 0 to 3
Adverse events Up to 1 month following the exacerbation Number of adverse events
FEV1/FVC ratio 1 month FEV1/FVC ratio at 1 month
Number of hospitalized patients during the month following the asthma attack Number of hospitalized patients
controlled asthma 1 month following the exacerbation Number of patients with a controlled asthma at 1 month following the exacerbation
FEV1 1 month FEV1 volume at 1 month
Time spent in ER Up to discharge from the emergency room Number of hours of stay in the ER
Number of medical visit 1 week and 1 month following the exacerbation Number of medical visits at 1 week and 1 month following the exacerbation
Total pulmonary capacity 1 month Total pulmonary capacity at 1 month
Vital capacity (VC) 1 month Vital capacity volume at 1 month
Pulmonary score Within 5 minutes following each inhalation procedure Pulmonary score at each procedure from 0 to 9
Oxygen saturation Within 5 minutes following each inhalation procedure Oxygen saturation at each procedure expressed as a percentage
Respiratory rate Within 5 minutes following each inhalation procedure Respiratory rate number of breathing cycles per minute
Score on the Asthma Control Questionnaire (ACT) 1 month after randomisation Score on the Asthma Control Questionnaire (ACT)
Trial Locations
- Locations (8)
CHU Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CHU Lille
🇫🇷Lille, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
CHU Antoine Béclère
🇫🇷Clamart, France
CHI Créteil
🇫🇷Créteil, France
Grand Hôpital de l'Est Francilien
🇫🇷Jossigny, France
CHI Villeneuve-Saint-Georges
🇫🇷Villeneuve-Saint-Georges, France
CHU Bicêtre
🇫🇷Le Kremlin-Bicêtre, France