Efficacy and Safety of Increasing Doses of Inhaled Albuterol Administered by Metered Dose Inhalers in Children With Acute Wheezing Episodes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Hospital Admission
研究概览
简要总结
Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
详细描述
This is a prospective, randomized, double blinded, controlled study. The patients will be randomly assigned to one of the treatment groups (experimental or control groups).
The patients will be assessed 1 hour later and every 30 minutes thereafter until discharge. Following 4 hours in the emergency room, any patient who do not meet the discharge criteria (PRAM score ≤ 3 and SpO2 ≥ 92%) will be admitted to the hospital. Each patient's attending physician will determine the need for additional therapies following the first hour.
Identification of respiratory viruses in the nasal lavage samples wil be performed using the CLART PneumoVir® kit.
Albuterol plasmatic levels will be analyzed via HPLC (High Performance Liquid Chromatography).
To genotype the ADBR2 receptor (blood samples), the gene regions encompassing the Arg16Gly, Gln27Glu, and Arg19Cys Thr164Ile polymorphisms will be amplified via PCR. The resultant amplimers were then sequenced.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 2 to 18 years;
- •History of two or more previous episodes of wheezing treated with bronchodilators in the last year;
- •Wheezing attacks characterized by coughing, difficulty breathing and auscultation of expiratory wheezing or prolonged expiration;
- •Intensity of wheezing attacks defined by PRAM score as moderate or severe (PRAM ≥ 5).
排除标准
- •Pre-existing chronic diseases such as bronchopulmonary dysplasia, cystic fibrosis, bronchiolitis obliterans or other chronic pulmonary or cardiovascular disease;
- •Initial clinical status indicating immediate ventilatory support, need for subcutaneous or intravenous bronchodilators;
- •Decreased level of consciousness;
- •Using a β-agonist in the four hours prior to arrival.
- •Use of corticosteroids in the last 24h.
研究组 & 干预措施
Albuterol - Experimental
Albuterol dosages during the first hour include 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg).
干预措施: Albuterol - Experimental (Drug)
Albuterol - Control
Albuterol dosages during the first hour include either 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg).
干预措施: Albuterol - Control (Drug)
结局指标
主要结局
Hospital Admission
时间窗: Starting at 4 hours post-treatment
Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)
次要结局
- Electrocardiogram at Baseline(at baseline)
- Changes in Respiratory Rate After One Hour(One hour post-treatment in comparison with baseline)
- Forced Expiratory Volume in the First Second(One hour post-treatment in comparison with baseline)
- Changes in Glucose Serum Levels(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.)
- Need for Additional Therapies(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
- Change in PRAM Score After One Hour(One hour post-treatment)
- Albuterol Determination in the Plasma(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
- Changes in PRAM Score at Discharge or Hospital Admission(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.)
- Changes in Potassium Serum Levels(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.)
- Changes in Bicarbonate Serum Levels(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.)
- Changes in Respiratory Rate at at Discharge or Hospital Admission.(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.)
- Change in Pulse Oximetry One Hour Post-treatment(One hour post-treatment in comparison with baseline)
- Changes in Pulse Oximetry at Discharge or Hospital Admission.(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.)
- Changes in Heart Rate After One Hour(One hour post-treatment in comparison with baseline)
- Changes in Heart Rate at Discharge or Hospital Admission(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
- Electrocardiogram One Hour Post-treatment.(One hour post-treatment)
- Electrocardiogram at Discharge or Hospital Admission(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
- Lengths of Stay in the Emergency Room(one to four hours)
- Admission Rates in Patients With and Without Any Virus Detected(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
- Admission Rates in Patients With and Without Rhinovirus Detect(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
- Admission Rates in Patients With the Arg16Gly Polymorphisms(at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment))
研究者
Luiz Vicente Ribeiro Ferreira da Silva Filho
MD PhD
University of Sao Paulo