Evaluation of the Impact of SIMEOX Airway Clearance Medical Device at Home, Combined With Remote Physiotherapy, on Quality of Life and Pulmonary Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis, Compared With Enhanced Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 622
- 试验地点
- 84
- 主要终点
- The annual rate of pulmonary exacerbations
研究概览
简要总结
Bronchiectasis is a chronic lung disease of multiple aetiologies characterised by permanent dilatation of the calibre of a territory of the bronchial tree with impaired mucociliary clearance. This alteration causes mucus retention, leading to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, in particular to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended that bronchial drainage sessions be carried out on a daily or more frequent basis, which represents a very substantial burden in terms of care. In addition, access to respiratory physiotherapy is not always easy for patients due to geographical or time constraints or the availability of professionals. Moreover, few professionals are trained in this specific care for chronic lung diseases.
SIMEOX (Physio-Assist, France) is an innovative medical device (CE medical mark) for draining the bronchial tree. By means of a mouthpiece, this device generates a succession of very short intermittent negative air pressure pulses which disseminate a pneumatic vibratory signal in the patient's bronchial tree, modifying the rheological properties of the mucus, facilitating the mobilisation of secretions and assisting their transport towards the upper airways.
A recent pilot study demonstrated that the use of SIMEOX independently by the patient at home for 3 months, combined with remote Physiotherapy (1 session/2 weeks), provided a very satisfactory bronchial drainage solution for patients (satisfaction assessed at 9/10 by visual analogue scale), with an improvement in their quality of life and very good compliance with the device (median of 4.7 sessions/week).
This bronchial drainage strategy requires a long-term assessment.
Hypothesis: the use of SIMEOX independently by the patient at home could improve long-term quality of life and reduce the rate of pulmonary exacerbations in non-cystic fibrosis (non-CF) patients with bronchiectasis (bronchial dilatation) in comparison to Standard of Care (SoC).
详细描述
Two main objectives will be assessed simultaneously:
- To compare the effect of SIMEOX, combined with remote Physiotherapy, with enhanced SoC (SoC + Remote Physiotherapy), on the quality of life related to the respiratory problems of patients at mid term.
- To compare the effect of SIMEOX, combined with remote Physiotherapy with enhanced SoC (SoC + Remote Physiotherapy) on the rate of respiratory exacerbations at long term.
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
- Single (Participant)
盲法说明
modified Zelen method: participants in the control group will not be aware of another group using the SIMEOX -> only one group is blinded
A blinded adjudication committee will review the outcome for one primary endpoint (exacerbations).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged over 18 years
- •Predominant diagnosis of Non CF bronchiectasis disease, excluding cystic fibrosis, confirmed by computed tomography (CT).
- •Regular and chronic sputum production
- •Clinically stable at inclusion
- •Defined by a delay of at least 4 weeks since the end of the last exacerbation according to the European consensus (Hill, European Respiratory Journal, 2017)
- •No change in disease-modifying treatment for 4 weeks.
- •Having had at least two pulmonary exacerbations in the 12 months prior to inclusion and having required a change in specific treatment for these exacerbations.
- •Or Having had at least one pulmonary exacerbation in the 12 months prior to inclusion requiring hospitalisation.
- •Considered by the investigator to be physically and psychologically able to use the device and carry out the procedures under study.
- •Patient covered by a social security system, when applicable in the concerned country
排除标准
- •Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion:
- •an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
- •intrapulmonary percussion ventilation (IPV)
- •Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:
- •a mechanical in-exsufflator (MI E) such as the Cough Assist
- •a pressure reducer such as the Alpha300
- •Cystic fibrosis
- •Predominant diagnosis of Chronic obstructive pulmonary disease (COPD) or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.
- •Active smoking
- •Suspected (but undiagnosed) or unstabilised immune deficiency (at investigator's discretion)
- •In the case of long-term immunosuppressive treatment, risk of discontinuation of this treatment during the study.
- •Unstable cardiovascular pathologies (acute coronary syndrome, unstable angina pectoris, uncontrolled rhythm disorders, unstable heart failure)
- •Haemodynamic instability
- •Uncontrolled gastro-oesophageal reflux (persistence of symptoms despite treatment), at investigator's discretion.
- •Acute pneumothorax or increased susceptibility to pneumothorax/pneumomediastinum
- •Inability to cough vigorously and independently, at investigator's discretion
- •Had a significant episode of haemoptysis in the 6 weeks prior to inclusion, at the discretion of the investigator
- •Patient using an endotracheal tube, tracheostomy tube or daytime ventilation >16h with a mask
- •Patients with neuromuscular disease and respiratory muscle weakness, at the discretion of the investigator
- •Recent cardiothoracic surgery, including oesophageal surgery within 3 months of inclusion
- •Severe acute lung injury or barotrauma within 3 months of inclusion
- •Difficulty in evacuating secretions from the upper airways due to weakness of the respiratory muscles, or of the oropharyngeal or buccal musculature, at the discretion of the investigator
- •Risk of airway aspiration, e.g. from tube feeding or recent meals, at investigator's discretion
- •Inspiratory muscle weakness with inability to tolerate increased work of breathing, at investigator's discretion
- •Severe restrictive disease (Total Lung Capacity < 60% with complete plethysmography)
- •Bullous emphysema
- •Participation in other interventional clinical study in the month prior to inclusion or during the study period
- •Patient unavailable or wishing to move to a region where the protocol is not present before the end of their participation
- •Vulnerable people:
- •pregnant women (verified by a urine or blood human chorionic gonadotropin (HCG) test for all women wishing to participate in the protocol and of childbearing age, without contraception), breastfeeding mothers or women planning to become pregnant during the period of participation in the clinical investigation
- •a person deprived of liberty by judicial or administrative decision
- •a person subject to a legal protection measure
研究组 & 干预措施
SIMEOX
SIMEOX device combined with Remote Physiotherapy + standard of care
干预措施: SIMEOX (Device)
SIMEOX
SIMEOX device combined with Remote Physiotherapy + standard of care
干预措施: Remote Physiotherapy (Other)
Control
Remote Physiotherapy + standard of care
干预措施: Remote Physiotherapy (Other)
结局指标
主要结局
The annual rate of pulmonary exacerbations
时间窗: Over the duration of the study (24 months in average)
The annual rate of pulmonary exacerbations observed per patient per year compared between the SIMEOX-treated group and the control group over the duration of the study (24 months in average).
Quality of life SGRQ at 6 months
时间窗: Change from baseline at 6 months
The change in the St George's Hospital Respiratory Questionnaire total quality of life score from baseline (inclusion) at 6 months of treatment, adjusted on the baseline score, with a comparison between the SIMEOX-treated group and the control group.
次要结局
- 3 domains of quality of life of the SGRQ at 6 months(Change from baseline at 6 months)
- 3 domains of quality of life of the SGRQ at 12 months(Change from baseline at 12 months)
- QoL-B questionnaire at 12 months(Change from baseline at 12 months)
- EQ5D-5L questionnaire at 12 months(Change from baseline at 12 months)
- EQ5D-5L questionnaire at 24 months(Change from baseline at 24 months)
- Proportion of compliant patients(Over the duration of the study (24 months in average))
- Quality of life SGRQ at 24 months(Change from baseline at 24 months)
- QoL-B questionnaire at 24 months(Change from baseline at 24 months)
- spirometry parameters : FEV1/FVC at 12 months(Change from inclusion at 12 months)
- Rate of respiratory exacerbations with hospitalisation over the duration of the study(Over the duration of the study (24 months in average))
- Proportion of patients with 2 or more exacerbations at 12 months(12 months)
- Proportion of patients with at least one hospitalisation for exacerbations at 6 months(6 months)
- Proportion of patients with at least one hospitalisation for exacerbations over the duration of the study(Over the duration of the study (24 months in average))
- The percentage of responder / non-responder patients at 24 months(24 months)
- EQ5D-5L questionnaire at 6 months(Change from baseline at 6 months)
- CAAT questionnaire at 6 months(Change from baseline at 6 months)
- spirometry parameters : FVC at 6 months(Change from inclusion at 6 months)
- spirometry parameters : FEV1/FVC at 24 months(Change from inclusion at 24 months)
- spirometry parameters : FEF 25-75% at 12 months(Change from inclusion at 12 months)
- spirometry parameters : FEF 25-75% at 24 months(Change from inclusion at 24 months)
- Time period before first exacerbation(Over the duration of the study (24 months in average))
- Rate of respiratory exacerbations with hospitalisation at 12 months(12 months)
- spirometry parameters : FEF 25-75% at 6 months(Change from inclusion at 6 months)
- Rate of respiratory exacerbations with hospitalisation at 6 months(6 months)
- Rate of respiratory exacerbations without hospitalisation at 6 months(6 months)
- Rate of respiratory exacerbations without hospitalisation at 12 months(12 months)
- Duration of hospitalisation for exacerbations at 6 months(6 months)
- Duration of hospitalisation for exacerbations at 12 months(12 months)
- CAAT questionnaire at 24 months(Change from baseline at 24 months)
- spirometry parameters : FEV1 at 6 months(Change from inclusion at 6 months)
- Rate of respiratory exacerbations without hospitalisation over the duration of the study(Over the duration of the study (24 months in average))
- Proportion of patients with 2 or more exacerbations at 6 months(6 months)
- Proportion of patients with at least one hospitalisation for exacerbations at 12 months(12 months)
- The percentage of responder / non-responder patients at 12 months(12 months)
- Quality of life SGRQ at 12 months(Change from baseline at 12 months)
- QoL-B questionnaire at 6 months(Change from baseline at 6 months)
- spirometry parameters : FEV1 at 24 months(Change from inclusion at 24 months)
- Duration of hospitalisation for exacerbations over the duration of the study(Over the duration of the study (24 months in average))
- Average number of sessions(Over the duration of the study (24 months in average))
- Number of adverse events(Over the duration of the study (24 months in average))
- 3 domains of quality of life of the SGRQ at 24 months(Change from baseline at 24 months)
- CAAT questionnaire at 12 months(Change from baseline at 12 months)
- spirometry parameters : FEV1 at 12 months(Change from inclusion at 12 months)
- spirometry parameters : FVC at 12 months(Change from inclusion at 12 months)
- spirometry parameters : FVC at 24 months(Change from inclusion at 24 months)
- spirometry parameters : FEV1/FVC at 6 months(Change from inclusion at 6 months)
- Proportion of patients with 2 or more exacerbations over the duration of the study(Over the duration of the study (24 months in average))