Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 17
- 主要终点
- Asthma Exacerbations
研究概览
简要总结
The objective of this study is to determine whether, in children receiving low-dose inhaled corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations reduces the rate of severe asthma exacerbations treated with oral corticosteroids.
详细描述
The study design is a double-blind, parallel-group trial, including a total of 250 participants, ages 5-11 years, with a diagnosis of asthma and a history of at least 1 asthma exacerbation treated with oral corticosteroids in the prior year. All participants will be treated for 48 weeks with open-label fluticasone 44 mcg 2 puffs twice daily. During the 48-week treatment period, participants will receive randomized blinded therapy for 7 days each time they enter the "yellow zone" (at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations). Yellow zone therapy will be fluticasone 44 or 220 mcg 2 puffs twice 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma
- •At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in the past 12 months
- •Able to perform reproducible spirometry
- •Current treatment with step 2 controller therapy [low-dose ICS, leukotriene receptor antagonist (LTRA)] OR current treatment with step 3 controller therapy [low-dose ICS + long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS] with a childhood Asthma Control Test (c-ACT) score of >19, no more than 2 prednisone treated exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1 second (FEV1) ≥ 80% predicted and willing to step down therapy OR controller naïve and qualifying for step 2 controller therapy [asthma symptoms or short acting beta agonist (SABA) use > 2 days per week or night-time awakenings due to asthma > 2 nights per month]
- •Prebronchodilator FEV1 ≥ 60% predicted
- •Ability and willingness to provide informed assent
- •For females of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method.
- •History of clinical varicella or varicella vaccine
排除标准
- •Systemic (oral or injectable) corticosteroids within previous 2-week period
- •Current or recent (previous 2-weeks) use of medications known to significantly interact with corticosteroid disposition, including but not limited to carbamazepine, erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole
- •Presence of chronic or active lung disease other than asthma
- •Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study
- •A history of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids
- •History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure
- •More than 5 prednisone treated exacerbations in the past 12 months
- •More than 1 hospitalizations lasting >24 hours for asthma in the past 12 months
- •History of adverse reactions to ICS preparations or any of their ingredients
- •Receiving hyposensitization therapy other than an established maintenance regimen (On maintenance regimen for ≥ 3 months)
- •History of premature birth before 35 weeks gestation
研究组 & 干预措施
Fluticasone 44 mcg
Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
干预措施: Fluticasone 44 mcg (Drug)
Fluticasone 220 mcg
Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
干预措施: Fluticasone 220 mcg (Drug)
结局指标
主要结局
Asthma Exacerbations
时间窗: end of 48 week treatment period
The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.
次要结局
- Number of Participants Hospitalized for Asthma(end of 48 week treatment period)
- Yellow Zone Asthma Symptoms(end of 48 week treatment period)
- Yellow Zone Albuterol Use(end of 48 week treatment period)
- Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma(end of 48 week treatment period)
研究者
dave mauger
Principal Investigator, AsthmaNet Data Coordinating Center
Milton S. Hershey Medical Center