A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
研究概览
简要总结
This study is a 24-week, randomized, parallel group comparative effectiveness study to evaluate the risk of stepping down therapy for patients with well-controlled asthma treated with combination Inhaled corticosteroids (ICS) and Leukotriene receptor antagonist（LTRA).
详细描述
Asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months. Leukotriene receptor antagonist（LTRA). For children with mild persistent asthma, ICS twice a day combined with LTRA can be used for treatment, but there is no consensus on how to reduce drugs in patients with asthma that is well controlled (reducing the dose of ICS or stopping montelukast). We propose a 24-week, randomized, parallel group comparative effectiveness study comparing three approaches in patients with asthma well-controlled for at least three months on combination ICS and LTRA: Halve the dose of ICS firstly and then stop ICS with montelukast only, stop montelukast firstly and then halve the dose of ICS, and halve the dose of ICS firstly and then stop montelukast. Our goal is to compare the rate of treatment failure and determine the optimal treatment strategy. Additional goals include assessing risk factors for step-down failure.
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
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 4-14 years
- •patients had mild to moderate persistent asthma. Patients have treated with low-dose inhaled corticosteroids (equivalent to Fluticasone propionate inhaled aerosol 250 ug/ day) combined with Leukotriene receptor antagonist (Montelulast) at least 6 months of and had no symptoms of asthma for nearly 3 months under well asthma control(Asthma Control Test (ACT) score more than or equal to 20).
- •patients did not suffer from other acute or chronic diseases that may affect their growth and development
排除标准
- •patients with severe persistent asthma or mild persistent asthma failed to be well controlled by low-dose ICS after starting treatment
- •suffer from other diseases: Congenital heart disease, chronic infectious disease, protracted diarrhea, congenital airway disease, congenital vascular ring malformation, congenital immune deficiency, tracheal foreign body, bronchial lymph node tuberculosis and gastroesophageal reflux etc.
- •patients with poor compliance stop medication or fail to take medication on time.
研究组 & 干预措施
Stop Fluticasone propionate Inhaled Aerosol Firstly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day
干预措施: Fluticasone propionate inhaled aerosol (Drug)
Stop Montelukast Secondly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day
干预措施: Fluticasone propionate inhaled aerosol (Drug)
Stop Montelukast Firstly
stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day
干预措施: Fluticasone propionate inhaled aerosol (Drug)
结局指标
主要结局
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
时间窗: Baseline (Week 0) to Week 24
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Asthma Control Test (ACT) score
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Change in participant's Asthma Control Test (ACT) score
次要结局
- Peak expiratory flow (PEF)(Baseline, 12 weeks and 24 weeks)
- Forced expiratory volume in one second in predicted（FEV1%pred）(Baseline, 12 weeks and 24 weeks)
- Forced vital capacity in predicted(FVC%pred)(Baseline, 12 weeks and 24 weeks)
- Fractional exhaled Nitric Oxide, FeNO(Baseline, 12 weeks and 24 weeks)
- Maximal mid expiratory flow in predicted(MMEF%pred)(Baseline, 12 weeks and 24 weeks)