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

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.

Study Overview

• Status: Completed
• Conditions: Non-cystic Fibrosis Bronchiectasis; Chronic Mucus Hypersecretion
• Intervention / Treatment: Device: Simeox; Combination product: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland, 30-688
    • Jagiellonian University Medical College
  • Lodz, Poland, 90-153
    • N. Barlicki University Hospital No 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simeox; Airway clearance device	Device: Simeox; Daily airway clearance therapy at home during 2 months; Combination product: Control; Daily airway clearance therapy at home during 2 months; Other Names: Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)
Active Comparator: Control; Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)	Combination product: Control; Daily airway clearance therapy at home during 2 months; Other Names: Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up	The evolution of device adherence will be described by % of self-reported sessions (0-1; 2-3; 4-7/week) by the patient over the 2-month FU (1 week, 2 weeks, 1 month and 2 months)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of Simeox on respiratory symptoms in NCFB patients after 2 months of therapy	The change in respiratory symptoms score from baseline (hospital discharge) to 2-month FU will be measured with the Chronic Airways Assessment Test (CAT) questionaire	2 months
To evaluate the effect of Simeox on the health-related quality of life of NCFB patients after 2 months of therapy	The change in quality of life from baseline (hospital discharge) to 2-month FU will be measured with the St Georges Respiratory Questionnaire (SGRQ)	2 months
To evaluate the effect of Simeox on Forced Expiratory Volume at 1 seconde (FEV1) after 2 monts of therapy	The change in FEV1 from baseline (hospital discharge) to 2-month FU will be measured with spirometry	2 months
To evaluate the effect of Simeox on Forced Vital Capacity (FVC) after 2 monts of therapy	The change in FVC from baseline (hospital discharge) to 2-month FU will be measured with spirometry	2 months
To evaluate the effect of Simeox on Forced Expiratory Flow (FEF) at 25%, 50% and 75% of FVC after 2 monts of therapy	The change in FEF at 25%, 50% and 75% from baseline (hospital discharge) to 2-month FU will be measured with spirometry	2 months
To evaluate the effect of Simeox on dyspnea after 2 monts of therapy	The change in dyspnea from baseline (hospital discharge) to 2-month FU will be measured with the modified Medical Research Council (mMRC) questionnaire	2 months
To evaluate the effect of Simeox on exercise capacity after 2 monts of therapy	The change in walking distance from baseline (hospital discharge) to 2-month FU will be measured with the 6-min walking test (6MWT)	2 months
To evaluate safety of Simeox	The safety of Simeox will be assessed by the rate and severity of Side effects during follow-up	2 months
To describe Simeox therapy settings (program selection) during follow-up	Simeox settings will be described by program selection (1, 2 or 3)	2 months
To describe Simeox therapy settings (intensity) during follow-up	Simeox settings will be described by intensity (25%, 50%, 75% or 100%)	2 months
To describe Simeox therapy settings (number of session) during follow-up	Simeox settings will be described by the number of sessions per day	2 months
To describe Simeox therapy settings (session duration) during follow-up	Simeox settings will be described by the session duration in minutes	2 months
To evaluate mucus quality with Simeox therapy during follow-up	Mucus quality will be evaluated during follow-up with a score from 1 to 4 (abondant - Scanty)	2 months
To evaluate breathing quality with Simeox therapy during follow-up	Breathing quality level will be evaluated during follow-up with a score from 1 to 4 (very good - very poor)	2 months
To evaluate ease handling of the Simeox device during follow-up	Ease of handling level will be evaluated during follow-up with a score 1 to 4 (very easy - not easy at all)	2 months
To evaluate pain during Simeox therapy	Pain level will be evaluated during follow-up with a scale from 0 to10 (no painful - very painful)	2 months
To evaluate fatigue during Simeox therapy	Fatigue level will be evaluated during follow-up with a scale from 0 to 10 (no fatigue - very tired)	2 months
To evaluate ease of use of Simeox device after 2 months of therapy	Ease of use level will be evaluated at 2 month with a score from 1 to 4 (very easy - not easy at all)	2 months
To evaluate patient preference between Simeox device and usual care after 2 months of therapy	Patient preference will be evaluated at 2 month in comparaison to conventional techniques used (yes/no)	2 months
To evaluate patient recommendation to others patients of Simeox device after 2 months of therapy	Patient recommendation to others patients will be evaluated at 2 month (yes/no)	2 months
Evaluate the feasibility of telecare during follow-up	Feasibility of telecare during follow-up will be estimated by the percent of call visit performed with the patients compared to the number of call visits scheduled in the protocol	2 months

Collaborators and Investigators

• Sponsor: Physio-Assist
• Collaborators: Medical University of Lodz; University Hospital in Krakow
• Investigators: Study Director: Wojciech PIOTROWSKI, MD, PhD, Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Bronchiectasis; Telecare; ACT; NCFB; Airway clearance; CMH; Simeox
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Bronchial Diseases; Fibrosis; Bronchiectasis
• Other Study ID Numbers: Simeox 1.1 290623

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No