Asthma in Children
Conditions
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)
Interventions
DRUGBudesonide 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).
DRUGnebulisation 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.
Sponsors
AstraZeneca
Centre Hospitalier Intercommunal Creteil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalized patients | during the month following the asthma attack | Number of hospitalized patients |
| Time spent in ER | Up to discharge from the emergency room | Number of hours of stay in the ER |
| Score for the inhalation technique | Immediately after each inhalation procedure | Score for the inhalation technique at each procedure from 0 to 3 |
| 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 |
| controlled asthma | 1 month following the exacerbation | Number of patients with a controlled asthma at 1 month following the exacerbation |
| Adverse events | Up to 1 month following the exacerbation | Number of adverse events |
| Score on the Asthma Control Questionnaire (ACT) | 1 week after randomisation | Score on the Asthma Control Questionnaire (ACT) |
| Total pulmonary capacity | 1 month | Total pulmonary capacity at 1 month |
| Vital capacity (VC) | 1 month | Vital capacity volume at 1 month |
| FEV1/FVC ratio | 1 month | FEV1/FVC ratio 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 |
| FEV1 | 1 month | FEV1 volume at 1 month |
Countries
France
Outcome results
None listed