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).
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
SIMEOX,
an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
intrapulmonary percussion ventilation (IPV)
a mechanical in-exsufflator (MI E) such as the Cough Assist
Parallel
SIMEOX
DeviceUse of the CE-marked SIMEOX medical device. No specific limitation of the number of use but recommendation to use it daily (and more if needed).
Remote Physiotherapy
Other interventionRemote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
Quality of life SGRQ 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.
The annual rate of pulmonary exacerbations
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 12 months
The change in total quality of life score measured by the St George's Respiratory Questionnaire from baseline at 12 months of treatment, adjusted for the baseline score, will be compared between the SIMEOX-treated group and the control group.
Quality of life SGRQ at 24 months
The change in total quality of life score measured by the St George's Respiratory Questionnaire from baseline at 24 months of treatment, adjusted for the baseline score, will be compared between the SIMEOX-treated group and the control group.
3 domains of quality of life of the SGRQ at 6 months
The change in scores of any of the 3 domains of quality of life of the St George's Respiratory Questionnaire from baseline at 6 months of treatment, adjusted for the score at inclusion, compared between the SIMEOX-treated group and the control group.
3 domains of quality of life of the SGRQ at 12 months
The change in scores of any of the 3 domains of quality of life of the St George's Respiratory Questionnaire from baseline at 12 months of treatment, adjusted for the score at inclusion, compared between the SIMEOX-treated group and the control group.
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