Clinical trial Recruiting at 45 sites Interventional Ages 18 and up

Evaluation of the SIMEOX Device for Bronchiectasis Management at Home

Official title: 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

Run by Physio-Assist · NCT06487273 · Data updated 2026-11-12

This study is testing if using the SIMEOX device along with remote physiotherapy can help people with bronchiectasis feel better and have fewer breathing problems compared to standard care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment468 (estimated)
SponsorPhysio-Assist
Industry-sponsored
Locations57 sites (Abbeville and 56 other locations)
StatusRecruiting
StartedFebruary 3, 2025
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedNovember 2, 2026
Trial IDNCT06487273 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with a confirmed diagnosis of non-cystic fibrosis bronchiectasis, experiencing regular sputum production and a history of pulmonary exacerbations.

Probably not a fit

Patients with cystic fibrosis or those who are not clinically stable may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the SIMEOX device, combined with remote physiotherapy, in managing non-cystic fibrosis bronchiectasis. It aims to compare the quality of life and the rate of respiratory exacerbations in patients using SIMEOX against those receiving standard care with remote physiotherapy. The study focuses on patients with chronic sputum production and a history of pulmonary exacerbations, assessing their clinical stability and ability to use the device. The goal is to provide a more accessible and effective treatment option for bronchiectasis patients who face challenges in receiving traditional physiotherapy.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life and reduce respiratory exacerbations for patients with non-cystic fibrosis bronchiectasis.

How similar studies have gone: While the use of devices for bronchial drainage is established, the specific application of SIMEOX in this context is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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
* Clinically stable at inclusion

  * 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.
* Having had at least two pulmonary exacerbations in the 12 months prior to inclusion and having required a change in specific treatment for these exacerbations.

Or Having had at least one pulmonary exacerbation in the 12 months prior to inclusion requiring hospitalisation.

* 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

Exclusion Criteria:

* Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion:

  * SIMEOX,
  * an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
  * intrapulmonary percussion ventilation (IPV)
* Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:

  * 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.

However, patients with COPD or asthma and concomitant bronchiectasis may be eligible if they present symptoms of bronchiectasis (e. g. persistent cough, excessive mucus production, fatigue, shortness of breath, chest pain, etc.) and meet the following conditions:

1. For patients with COPD: bronchiectasis affecting at one or more pulmonary segment in at least two pulmonary lobes, as defined by the EMBARK group COPD-bronchiectasis association criteria (ROSE criteria);
2. For patients with asthma: documented evidence of bronchiectasis exacerbations (e.g., increased sputum production, sputum purulence, or infective exacerbation) requiring treatment with antibiotics, rather than exacerbation predominantly caused by bronchospasm or loss of asthma control

   * 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
   * Had a significant episode of haemoptysis in the 6 weeks prior to inclusion, at the discretion of the investigator
   * Patient using an endotracheal tube, tracheostomy tube or daytime ventilation \>16h with a mask
   * Patients with neuromuscular disease and respiratory muscle weakness, at the discretion of the investigator
   * Recent cardiothoracic surgery, including oesophageal surgery within 3 months of inclusion
   * Severe acute lung injury or barotrauma within 3 months of inclusion
   * Difficulty in evacuating secretions from the upper airways due to weakness of the respiratory muscles, or of the oropharyngeal or buccal musculature, at the discretion of the investigator
   * Risk of airway aspiration, e.g. from tube feeding or recent meals, at investigator's discretion
   * Inspiratory muscle weakness with inability to tolerate increased work of breathing, at investigator's discretion
   * Severe restrictive disease (Total Lung Capacity \< 60% with complete plethysmography)
   * Bullous emphysema
   * Participation in other interventional clinical study in the month prior to inclusion or during the study period
   * Patient unavailable or wishing to move to a region where the protocol is not present before the end of their participation
   * Vulnerable people:

     * pregnant women (verified by a urine or blood human chorionic gonadotropin (HCG) test for all women wishing to participate in the protocol and of childbearing age, without contraception), breastfeeding mothers or women planning to become pregnant during the period of participation in the clinical investigation
     * a person deprived of liberty by judicial or administrative decision
     * a person subject to a legal protection measure

Where it's running

  • CH Abbeville
    Abbeville, France
    Recruiting
  • CH Aix en Provence
    Aix-en-Provence, France
    Recruiting
  • CH Albi
    Albi, France
    Recruiting
  • Clinique Victor Pauchet
    Amiens, France
    Recruiting
  • CHU Amiens Picardie
    Amiens, France
    Recruiting
  • CHU Angers
    Angers, France
    Recruiting
Show 44 more locations
  • CH Annecy
    Annecy, France
    Recruiting
  • Clinique Aressy
    Aressy, France
    Recruiting
  • CHRU Brest
    Brest, France
    Recruiting
  • CH Cotentin
    Cherbourg, France
    Recruiting
  • CH Compiègne-Noyon
    Compiègne, France
    Recruiting
  • CH Alpes-Léman
    Contamine-sur-Arve, France
    Recruiting
  • CHI Créteil
    Créteil, France
    Recruiting
  • CFR Dieulefit
    Dieulefit, France
    Recruiting
  • CHU Grenoble-Alpes
    Grenoble, France
    Recruiting
  • HCL - centre de Hyères
    Hyères, France
    Recruiting
  • CH Le Puy-en-Velay
    Le Puy-en-Velay, France
    Recruiting
  • CH Libourne
    Libourne, France
    Recruiting
  • CHU Limoges
    Limoges, France
    Recruiting
  • HCL- Hôpital Croix-Rousse
    Lyon, France
    Recruiting
  • Hôpital Européen de Marseille
    Marseille, France
    Recruiting
  • Montpellier Hospital Center
    Montpellier, France
    Recruiting
  • CHU Nice
    Nice, France
    Recruiting
  • CHU Nîmes
    Nîmes, France
    Recruiting
  • Hôpital Cochin (AP-HP)
    Paris, France
    Recruiting
  • CH Pau
    Pau, France
    Recruiting
  • CHU Poitiers
    Poitiers, France
    Recruiting
  • CHU Reims
    Reims, France
    Recruiting
  • CHU Rennes
    Rennes, France
    Recruiting
  • Fondation Ildys
    Roscoff, France
    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, Germany
    Recruiting
  • LMU Klinikum
    München, Germany
    Recruiting
  • Uniwersytet Medyczny w Łodzi Nr 1 im. Norberta Barlickiego
    Lodz, Poland
    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, United Kingdom
    Recruiting
  • NHS Lothian
    Edinburgh, United Kingdom
    Recruiting
  • Royal Brompton & Harefield Hospitals, Guy's & St Thomas' NHS Foundation Trust
    London, United Kingdom
    Recruiting
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Newcastle upon Tyne, United Kingdom
    Recruiting
  • Groupe Hospitalier La Rochelle - Ré-Aunis
    La Rochelle, France
    Suspended
  • Hôpital Bicêtre (AP-HP)
    Le Kremlin-Bicêtre, France
    Withdrawn
  • Groupe Hospitalier du Havre
    Montivilliers, France
    Withdrawn
  • CH Perpignan
    Perpignan, France
    Not yet recruiting
  • CHU Rouen
    Rouen, France
    Withdrawn

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.