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

NCT06487273 | Recruiting DMC

• 1 other identifier: 2023-A01095-40
• Study Type: interventional
• Target: 622
• Locations: 6 countries
• Sites: 57

Brief 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).

Conditions

Non-cystic Fibrosis Bronchiectasis

Keywords

Non-CF Bronchiectasis; Bronchial clearance

Outcome Measures

Primary Outcomes (2)

• Quality of life SGRQ at 6 months

  The change in the St George's Hospital Respiratory Questionnaire total quality of life score from baseline (inclusion) at 6 months of treatment, adjusted on the baseline score, with a comparison between the SIMEOX-treated group and the control group.

  Change from baseline at 6 months

• The annual rate of pulmonary exacerbations

  The annual rate of pulmonary exacerbations observed per patient per year compared between the SIMEOX-treated group and the control group over the duration of the study (24 months in average).

  Over the duration of the study (24 months in average)

Secondary Outcomes (47)

• Quality of life SGRQ at 12 months

  Change from baseline at 12 months

• Quality of life SGRQ at 24 months

  Change from baseline at 24 months

• 3 domains of quality of life of the SGRQ at 6 months

  Change from baseline at 6 months

• 3 domains of quality of life of the SGRQ at 12 months

  Change from baseline at 12 months

• 3 domains of quality of life of the SGRQ at 24 months

  Change from baseline at 24 months

Study Arms (2)

Control

OTHER

Remote Physiotherapy + standard of care

Other: Remote Physiotherapy

SIMEOX

EXPERIMENTAL

SIMEOX device combined with Remote Physiotherapy + standard of care

Device: SIMEOX; Other: Remote Physiotherapy

Interventions

SIMEOX DEVICE

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).

SIMEOX

Remote Physiotherapy OTHER

Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after

Control; SIMEOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Defined by a delay of at least 4 weeks since the end of the last exacerbation according to the European consensus (Hill, European Respiratory Journal, 2017)
• No change in disease-modifying treatment for 4 weeks.
• Considered by the investigator to be physically and psychologically able to use the device and carry out the procedures under study.
• Patient covered by a social security system, when applicable in the concerned country

You may not qualify if:

• SIMEOX,
• an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
• intrapulmonary percussion ventilation (IPV)
• a mechanical in-exsufflator (MI E) such as the Cough Assist
• a pressure reducer such as the Alpha300
• 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

Sponsors & Collaborators

• Icadom: collaborator
• Clinact: collaborator
• Physio-Assist: lead

Study Sites (57)

CH Abbeville

Abbeville, France

RECRUITING

CH Aix en Provence

Aix-en-Provence, France

RECRUITING

CH Albi

Albi, France

RECRUITING

Clinique Victor Pauchet

Amiens, 80090, France

RECRUITING

CHU Amiens Picardie

Amiens, France

RECRUITING

CHU Angers

Angers, 49033, France

RECRUITING

CH Annecy

Annecy, France

RECRUITING

Clinique Aressy

Aressy, 64320, France

NOT YET RECRUITING

CHRU Brest

Brest, 29200, France

RECRUITING

CH Cotentin

Cherbourg, France

RECRUITING

CH Compiègne-Noyon

Compiègne, 60200, France

RECRUITING

CH Alpes-Léman

Contamine-sur-Arve, 74130, France

RECRUITING

CHI Créteil

Créteil, 94000, France

RECRUITING

CFR Dieulefit

Dieulefit, France

RECRUITING

CHU Grenoble-Alpes

Grenoble, 38043, France

RECRUITING

HCL - centre de Hyères

Hyères, France

RECRUITING

Groupe Hospitalier La Rochelle - Ré-Aunis

La Rochelle, France

SUSPENDED

Hôpital Bicêtre (AP-HP)

Le Kremlin-Bicêtre, 94270, France

WITHDRAWN

CH Le Puy-en-Velay

Le Puy-en-Velay, 43000, France

RECRUITING

CH Libourne

Libourne, 33500, France

RECRUITING

CHU Limoges

Limoges, France

RECRUITING

HCL- Hôpital Croix-Rousse

Lyon, 69004, France

RECRUITING

Hôpital Européen de Marseille

Marseille, France

RECRUITING

Groupe Hospitalier du Havre

Montivilliers, France

NOT YET RECRUITING

Montpellier Hospital Center

Montpellier, 34090, France

RECRUITING

CHU Nice

Nice, 06002, France

RECRUITING

CHU Nîmes

Nîmes, 30900, France

RECRUITING

Hôpital Cochin (AP-HP)

Paris, 75014, France

RECRUITING

CH Pau

Pau, 64000, France

RECRUITING

CH Perpignan

Perpignan, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, 86021, France

NOT YET RECRUITING

CHU Reims

Reims, 51092, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

Fondation Ildys

Roscoff, 29684, France

RECRUITING

CHU Rouen

Rouen, France

NOT YET RECRUITING

CH St Quentin

Saint-Quentin, France

RECRUITING

Hôpital Foch

Suresnes, France

RECRUITING

CH Tarbes Lourdes

Tarbes, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CH Troyes

Troyes, France

RECRUITING

CH Bretagne Atlantique

Vannes, France

RECRUITING

Medizinische Klinik V University hospital

Aachen, 52074, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

NOT YET RECRUITING

LMU Klinikum

München, 80336, Germany

ACTIVE NOT RECRUITING

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

NOT YET RECRUITING

Uniwersytet Medyczny w Łodzi Nr 1 im. Norberta Barlickiego

Lodz, 90-153, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-355, Poland

NOT YET RECRUITING

Centro Clínico Académico de Braga (2CA-Braga) ULS de Braga

Braga, 4710-243, Portugal

NOT YET RECRUITING

Hospital Senhora de Oliveira Guimarães ULS Alto Ave

Creixomil, 4835-044, Portugal

NOT YET RECRUITING

Instituto CUF

Porto, 4460-188, Portugal

NOT YET RECRUITING

CHU La Réunion Félix Guyon

Saint-Denis, Reunion

RECRUITING

CHU La Réunion Sud

Saint-Pierre, Reunion

RECRUITING

Royal Victoria Hospital, Belfast Health and Social Care Trust

Belfast, BT12 6BA, United Kingdom

NOT YET RECRUITING

Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

NOT YET RECRUITING

NHS Lothian

Edinburgh, EH3 9DN, United Kingdom

NOT YET RECRUITING

Wythenshawe Hospital, Manchester University, NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

NOT YET RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• Hamidfar R, Murris-Espin M, Mahot M, Abouly R, Gauchez H, Jacques S, Joffray E, Arnol N, Morin L, Leroy S, Borel JC. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023 Jul;10(1):e001722. doi: 10.1136/bmjresp-2023-001722.

  PMID: 37524523 BACKGROUND

Study Officials

• Sylvie Leroy, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Périnet-Marquet

CONTACT

+33 7 63 23 66 15; p.perinet-marquet@icadom.com

Laurent Morin

CONTACT

+33 6 03 27 30 12; laurent.morin@inogen.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: modified Zelen method: participants in the control group will not be aware of another group using the SIMEOX -\> only one group is blinded A blinded adjudication committee will review the outcome for one primary endpoint (exacerbations).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, randomised according to modified Zelen method in two steps, controlled, multi-sites clinical investigation 2 groups : comparison of SIMEOX + remote Physiotherapy + standard of care versus remote Physiotherapy + standard of care

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RE (2); FR (41); PL (3); DE (3); GB (5); PT (3)