Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Restech Srl
- 入组人数
- 39
- 试验地点
- 16
- 主要终点
- Symptoms
研究概览
简要总结
Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide.
Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function.
The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6-65 years old
- •Diagnosis of persistent asthma
- •Treatment level at study entry:
- •For children 6-11 years: Step2 or Step3 of the GINA document
- •For adolescents and adults 12-65 years: Step2 under daily low-dose inhaled corticosteroids (ICS), Step 3 or Step 4 of the GINA document
- •Uncontrolled asthma (ACQ-5 > 1.5) that, according to the physician, does not warrant an immediate step-up of the treatment
- •History of moderate or severe exacerbations in the twelve (12) months prior to baseline visit
排除标准
- •Use of oral, rectal or parenteral glucocorticosteroids 30 days before enrolment
- •Treatment with leukotriene receptor antagonist (LTRA)
- •Treatment with maintenance and reliever therapy (SMART/MART)
- •Smoking, current or previous with a history of 10 pack-years or more
- •Documented COPD or other concomitant clinically important diseases or cognitive impairment that, according to the physician, may interfere with the subject's ability or safety to participate in the study
- •Obesity (for subjects 6-19 years: BMI ≥ 95th percentile; for adults 20-65 years: BMI ≥ 40kg⋅m-2
- •For school-age children (6-11 years old): gestational age at birth < 37 weeks or documented bronchopulmonary dysplasia (BPD)
- •Prolonged absence from home during the monitoring period (i.e. at recruitment, expected ≥3 consecutive weeks for ≥2 times during the 9- month monitoring period) Subject currently enrolled in other clinical trials related or involving the study of the respiratory system
- •History of near-fatal asthma
- •Women who are pregnant, nursing or intending to become pregnant during the time of the study
- •Absence of health insurance coverage (applies to French centres only)
结局指标
主要结局
Symptoms
时间窗: From month no. 2 through study completion, an average of 7 months
Change of percentage of days with non-increased symptoms from baseline
Asthma Control
时间窗: 6 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
次要结局
- Day-to-day variability of respiratory resistance(Through study completion, an average of 9 months)
- Accuracy of CVRinsp in detecting exacerbations(Through study completion, an average of 9 months)
- Absence days from school/work(Through study completion, an average of 9 months)
- Exacerbation(Through study completion, an average of 9 months)
- Controller medication usage(From month no. 2 through study completion, an average of 7 months)
- Asthma Control(9 months from enrolment)