NCT06487273

Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 622 (estimated)
• Sponsor: Physio-Assist · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Non-cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DEVICE	SIMEOX	Use 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).
OTHER	Remote Physiotherapy	Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after

Timeline

• Start date: 2025-02-03
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-07-05
• Last updated: 2026-02-17

Locations

57 sites across 6 countries: France, Germany, Poland, Portugal, Reunion, United Kingdom