Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 40
- 主要终点
- Variation of forced expiratory volume in 1 second (FEV1)
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, post-care, 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with Cystic fibrosis
- •Stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment.
- •Requiring at least 1 bronchial clearing session each week (regardless of the technique)
- •Patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol.
排除标准
- •Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day.
- •Patient placed on a transplant waiting list
- •Any contraindication to an instrumental bronchial clearance technique
- •Patients already own and use SIMEOX at home
- •Unavailable patient or patient wishing to move to a different region within three months after inclusion.
- •Patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment.
- •Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age < 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure.
- •Initiation of treatment with a CFTR modulator within the last 3 months
结局指标
主要结局
Variation of forced expiratory volume in 1 second (FEV1)
时间窗: Change from baseline at 3 months
Relative variation of the forced expiratory volume in 1 second (FEV1) in the SIMEOX® treated group versus control group
Respiratory score of CFQ-R questionnaire
时间窗: Change from baseline at 3 months
Relative variation in respiratory score of the CFQ-R questionnaire (Cystic Fibrosis Questionnaire -revised version) in the SIMEOX® treated group versus control group. Score range from 0 to 100, with higher score indicating better health.
次要结局
- Total score of CFQ-R questionnaire(Change from baseline at 3 months)
- Forced expiratory flow(Change from baseline at 3 months)
- Static lung compliance in Liter(Change from baseline at 3 months)
- Exacerbation rate(After 3 months of use)
- First exacerbation(During 3 months of use)
- FEV1/ FVC ratio(Change from baseline at 3 months)
- Pulmonary forced vital capacity (FVC)(Change from baseline at 3 months)
- Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status(Change from baseline at 3 months)
- Physical activity assessed by step counts and moderate-to-vigorous physical activity(Change from baseline at 3 months)
- Fatigue assessed by VAS (visual analogue scale)(During 3 months of use)
- Hospitalization rate(After 3 months of use)
- Safety of use assessed by incidence of Treatment-Emergent Adverse Events(During 3 months of use)
- Acceptability assessed by the number of uses of SIMEOX® device(During 3 months of use)
- Static lung compliance in % of predicted value(Change from baseline at 3 months)
- Diffusion capacity for carbon monoxide(Change from baseline at 3 months)
- Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire(After 3 months of use)
- Airway resistance(Change from baseline at 3 months)
- Hospitalization duration(After 3 months of use)
- Antibiotic therapy(After 3 months of use)
- Adherence telemonitoring feasibility(After 3 months of use)
- Sleep quality assessed by sleep efficiency and fragmentation(Change from baseline at 3 months)
- Dyspnea assessed by mMRC (Modified Medical Research Council) score(Change from baseline at 3 months)
- Acceptability of SIMEOX-ANDROID application assessed by self-questionnaire AES (acceptability E-SCALE)(After 3 months of use)