Budesonide Inhalation Suspension for Acute Asthma in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Median Change in Asthma Score 2 Hours After Intervention
研究概览
简要总结
The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.
详细描述
Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children.
Objective
To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare.
Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.
Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.
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
- Triple (Participant, 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
- •Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
- •Males or females age 2 to 18 years
- •Weight greater than or equal to 10 kilograms
- •Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
- •Identified in triage as either "acute" or "critical"
- •Asthma score of 8 or greater
- •Systemic corticosteroid prescribed in the Emergency Department
- •English-speaking parent/guardian present
- •Parental/guardian permission (informed consent) and if appropriate, child assent
排除标准
- •Systemic corticosteroid use in the last 30 days
- •Chronic lung diseases including cystic fibrosis
- •Sickle cell anemia
- •Immunodeficiency
- •Cardiac disease requiring surgery or medications
- •Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
- •Known renal or hepatic dysfunction
- •Exposure to varicella in the last 21 days
- •Impending respiratory failure requiring positive pressure ventilation
- •Altered level of consciousness
- •Suspected foreign body aspiration or croup
- •Prior enrollment in the study
研究组 & 干预措施
Saline Placebo
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Prednisolone, prednisone, or methylprednisolone (Drug)
Saline Placebo
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Albuterol, ipratropium bromide (Drug)
Saline Placebo
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Ipratropium bromide (Drug)
Budesonide Inhalaiton Suspension
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg (Drug)
Budesonide Inhalaiton Suspension
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Prednisolone, prednisone, or methylprednisolone (Drug)
Budesonide Inhalaiton Suspension
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Albuterol, ipratropium bromide (Drug)
Budesonide Inhalaiton Suspension
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.
干预措施: Ipratropium bromide (Drug)
结局指标
主要结局
Median Change in Asthma Score 2 Hours After Intervention
时间窗: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.
Mean Change in Asthma Score at 2 Hours
时间窗: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.
次要结局
- Number of Patients Hospitalized(within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo)
- Change in Mean Heart Rate(From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator)
- Mean Change in Respiratory Rate.(Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator)
- Oxygen Saturation.(2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator)
- Number of Subjects Remaining in the Severe Asthma Category(From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator)
- Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category(From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator)
- Number of Subjects Moving From the Severe Asthma to Mild Asthma Category(From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator)
- Relapse / Readmission Numbers.(within 5 days of ED visit)
- Number of Participants With Adverse Events (Non-serious).(within 30 days of the ED visit)
- Serious Adverse Events(0-5 days)