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

NCT ID: NCT06237348

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2024-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simeox

Airway clearance device

Group Type: EXPERIMENTAL

Simeox

Intervention Type: DEVICE

Daily airway clearance therapy at home during 2 months

Control

Intervention Type: COMBINATION_PRODUCT

Daily airway clearance therapy at home during 2 months

Control

Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: COMBINATION_PRODUCT

Daily airway clearance therapy at home during 2 months

Interventions

Simeox

Daily airway clearance therapy at home during 2 months

Intervention Type: DEVICE

Control

Daily airway clearance therapy at home during 2 months

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)

Eligibility Criteria

Inclusion Criteria

• Patient with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD
• Overproduction of mucus (ie: estimated bronchorrhea >10mL/day).
• Pulmonary exacerbation (in- or outpatients)
• Age > 18 years old
• Patient able to understand the study and to perform the 2-month follow up visit

Exclusion Criteria

• Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
• Recent episode of severe haemoptysis
• Unstable severe cardiac disease or hemodynamic instability
• Cystic fibrosis or COPD as dominant diagnosis
• Patient on lung transplant list
• Severe lung injuries
• Recent lung surgery
• Inhalation support (continuous ventilatory support)
• Tracheostomy
• Uncontrolled GERD
• Any contraindication to an instrumental bronchial clearance technique (up to the investigator)
• Inability to perform PFT or 6MWT
• Patient not available or wishing to move to a different region within 2 months of inclusion
• Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures.
• Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: collaborator

University Hospital in Krakow

OTHER

Sponsor Role: collaborator

Physio-Assist

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wojciech PIOTROWSKI, MD, PhD

Role: STUDY_DIRECTOR

Medical University of Lodz

Locations

Jagiellonian University Medical College

Krakow, , Poland

N. Barlicki University Hospital No 1

Lodz, , Poland

Countries

Poland

Other Identifiers

Simeox 1.1 290623

Identifier Type: -

Identifier Source: org_study_id