Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 6
- 主要终点
- Proportion of episode-free days as determined by diary cards
研究概览
简要总结
This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children with recurrent severe wheezing.
详细描述
Acute Intervention Management Strategies (AIMS) is a randomized, double-blind, double-dummy, placebo-controlled parallel comparison study that will compare the effectiveness of three treatments, when given at the onset of RTI-associated symptoms, in increasing the proportion of symptom-free days over the entire treatment period of the 5- to 9-month study. There will be a 2-week period to qualify and characterize participants, who at that time will have no lower respiratory tract symptoms other than mild cough. A total of 244 participants will be randomized to one of three treatment groups and followed for the remainder of the fall-winter-early spring season. Participants will receive one of the following treatment regimens for 7 days, at the first sign of RTI-associated symptoms: 1) active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily; 2) active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily; or 3) placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent episodes (at least two) of wheezing in the context of a RTI, at least one of which must be documented by a health care provider (parental report) over the 12 months prior to study entry, and of which one episode must have occurred within 6 months prior to study entry
- •Either two episodes of '1,' OR two episodes of '2,' OR one episode of '1' AND one episode of '2,' defined by the following:
- •Urgent care visit for acute wheezing (emergency department, urgent care center, or unscheduled primary care physician office visit), which required treatment with a bronchodilator, within 12 months prior to study entry
- •Episode of wheezing within 12 months prior to study entry, which required treatment with oral corticosteroids not associated with a visit to a health care provider, urgent care center, emergency department, or hospital
- •Immunizations are up to date, including varicella (unless the patient has already had clinical varicella)
- •Willingness to provide informed consent by patient's parent or guardian
排除标准
- •Use of more than six courses of systemic corticosteroids during the 12 months prior to study entry
- •More than two hospitalizations for wheezing illnesses within 12 months prior to study entry
- •Use of long-term controller medications for asthma (including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline) for 4 or more months (cumulative use) within 1 year prior to study entry
- •Any use of long-term controller medications for asthma (including corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) within the 2 weeks prior to the enrollment visit
- •Current treatment with antibiotics for diagnosed sinus disease
- •Contraindication of use of systemic corticosteroids
- •Prematurity (defined as birth before 36 weeks gestational age)
- •Presence of lung disease other than asthma (e.g., cystic fibrosis and BPD)
- •Presence of other significant medical illnesses (e.g., cardiac, liver, gastrointestinal, or endocrine disease) that would place the patient at increased risk
- •Gastroesophageal reflux under medical therapy
- •Immunodeficiency disorders
- •History of respiratory failure requiring mechanical ventilation
- •History of hypoxic seizure
- •Inability to cooperate with nebulization therapy
- •Inability to ingest the study drugs
- •History of significant adverse reaction to any study medication ingredient
- •Current participation, or participation in the month prior to study entry, in another investigational drug study
- •Evidence that the family may be unreliable, nonadherent, or likely to move from the clinical center area before study completion
- •Persistent symptomatic asthma, as defined as experiencing symptoms (i.e., nocturnal cough, daytime cough, wheezing, difficulty breathing, or symptoms interfering with activities) and/or requiring albuterol use on average 4 or more days per week in the 2-week observation period prior to the randomization visit
- •The following scores, based on a 5-point scale with 5 representing very severe symptoms (measured at randomization visit): score equal to or greater than one for albuterol use, wheezing, difficulty breathing, nighttime cough, and asthma symptoms interfering with activities; score greater than 2 for daytime cough on an average of 4 or more days/week during the 2-week observation period
- •Failure to complete diary cards at expected levels (at least 80% of days) during the observation period
- •Use of long-term controller medications for asthma (e.g., corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) during the 2-week observation period
研究组 & 干预措施
1
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
干预措施: Inhaled Corticosteroid (Budesonide) (Drug)
1
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
干预措施: Inhaled Albuterol (Drug)
2
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
干预措施: Leukotriene Receptor Antagonist (Montelukast Sodium) (Drug)
2
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
干预措施: Inhaled Albuterol (Drug)
3
Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
干预措施: Inhaled Albuterol (Drug)
结局指标
主要结局
Proportion of episode-free days as determined by diary cards
时间窗: Measured over 12-month follow-up period
次要结局
- Number of wheezing episodes(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Time to treatment failure(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Measures of patient and family morbidity(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Time to initiation of first course of oral corticosteroids(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Total number of courses of oral corticosteroids(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Duration and severity of lower respiratory tract symptoms(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Number of unscheduled visits for acute wheezing episodes(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Linear growth(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)