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临床试验/NCT04095078
NCT04095078已完成不适用

Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study

Physio-Assist10 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Physio-Assist
入组人数
56
试验地点
10
主要终点
Pulmonary static hyperinflation assessed by residual volume

研究概览

简要总结

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc...). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

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
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • one of the 56 first patients of HOME-CARE SIMEOX study
  • same criteria as HOME-CARE SIMEOX study

排除标准

  • same criteria as HOME-CARE SIMEOX study

结局指标

主要结局

Pulmonary static hyperinflation assessed by residual volume

时间窗: Change from baseline at 3 months

Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.

次要结局

  • Use assessed by the duration of use of SIMEOX® device(During 3 months of use)
  • Inspiratory capacity(Change from baseline at 3 months)
  • Residual functional capacity (RFC)(Change from baseline at 3 months)
  • Total lung capacity (TLC)(Change from baseline at 3 months)

研究者

发起方
Physio-Assist
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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