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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).
Full description
Two main objectives will be assessed simultaneously:
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Inclusion criteria
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
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.
Exclusion criteria
Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion:
Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:
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 (Forced Vital Capacity < 60% or 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:
Primary purpose
Allocation
Interventional model
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622 participants in 2 patient groups
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Central trial contact
Laurent Morin; Pauline Périnet-Marquet
Data sourced from clinicaltrials.gov
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