NCT06237348

Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH

Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Physio-Assist · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot RCT will assess benefits of Simeox technology on lung function, respiratory symptoms, health-related quality of life, subjective efficiency, device adherence at home, Patient satisfaction, tolerance, safety, and telecare feasibility.

Detailed description

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic respiratory disease with multiple etiologies characterized by an irreversible dilatation of bronchi and an impair mucociliary clearance. These alterations cause sticky mucus retention and leads to recurrent infections and chronic bronchial inflammations. Chest physiotherapy is one of the cornerstones of the management of NCFB patients, particularly to facilitate airway clearance. In NCFB patients with chronic mucus hypersecretion (CMH), it is recommended that airway clearance sessions be carried out daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy for patients can be limited due to several causes: geographical, time or healthcare professional availability constraints. In addition, few healthcare professionals are trained for bronchial drainage especially with airway clearance devices. SIMEOX® (Physio-Assist, France) is an innovative medical device (CE medical mark) for mucus clearance. The device is connected to patient mouth with an expiratory kit circuit. When the patient starts up the device during exhalation only, SIMEOX® disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration. After device training with respiratory physiotherapist, patients can be treated at hospital and use SIMEOX® in autonomy at home. Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals. The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX® in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation (in- or outpatients) in comparison to standard of care.

Conditions

• Non-cystic Fibrosis Bronchiectasis
• Chronic Mucus Hypersecretion

Interventions

Type	Name	Description
DEVICE	Simeox	Daily airway clearance therapy at home during 2 months
COMBINATION_PRODUCT	Control	Daily airway clearance therapy at home during 2 months

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-02-01
• Last updated: 2025-03-04

Locations

2 sites across 1 country: Poland