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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 8
- 主要终点
- Percentage of success
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
budesonide/formoterol Turbuhaler®
After randomization, patients in the experimental arm will receive budesonide/formoterol Turbuhaler® 100/6 μg, one inhalation every 5 minutes (Maximum 12 inhalations).
干预措施: Budesonide Formoterol Drug Combination (Drug)
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.
干预措施: nebulisation of terbutaline (Drug)
结局指标
主要结局
Percentage of success
时间窗: 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.
次要结局
- Score for the inhalation technique(Immediately after each inhalation procedure)
- Adverse events(Up to 1 month following the exacerbation)
- FEV1/FVC ratio(1 month)
- Number of hospitalized patients(during the month following the asthma attack)
- Score on the Asthma Control Questionnaire (ACT)(1 month after randomisation)
- controlled asthma(1 month following the exacerbation)
- FEV1(1 month)
- Time spent in ER(Up to discharge from the emergency room)
- Number of medical visit(1 week and 1 month following the exacerbation)
- Total pulmonary capacity(1 month)
- Vital capacity (VC)(1 month)
- Pulmonary score(Within 5 minutes following each inhalation procedure)
- Oxygen saturation(Within 5 minutes following each inhalation procedure)
- Respiratory rate(Within 5 minutes following each inhalation procedure)