Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in total lung resistance
研究概览
简要总结
Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology
- •willing and able to cooperate and learn new technic of drainage.
- •age 8-18 years, on the date of admission to hospital.
- •confirmed diagnosis of CF as determined by the investigator.
- •able to perform pulmonary tests
排除标准
- •History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following:
- •contraindications to bronchial chest physiotherapy
- •hemoptysis
- •pneumothorax
- •heart disease
- •recent chest surgery
- •recent chest injury
- •history of lung transplantation
结局指标
主要结局
Change in total lung resistance
时间窗: 1 month
Evolution of R5hz - Impulse Oscillometry (IOS) from baseline
次要结局
- Pulmonary exacerbation(1 month)
- Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)(1 month)
- Change in Forced Vital Capacity (FVC)(1 month)
- Change in Mean Mid Expiratory Flow (MMEF)(1 month)
- Change in lung clearance index (LCI)(1 month)
- Change in area of reactance (AX)(1 month)
- Change in central lung resistance(1 month)
- Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume(1 month)
- Change in Forced Expiratory Volume in 1 second (FEV1)(1 month)
- Change in total lung reactance(1 month)
- Change in Residual Volume (RV)(1 month)
- Change in peripheral lung resistance(1 month)
- Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire(1 month)
- Adverse events(1 month)