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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 468 (estimated) |
| Sponsor | Physio-Assist Industry-sponsored |
| Locations | 57 sites (Abbeville and 56 other locations) |
| Status | Recruiting |
| Started | February 3, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06487273 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
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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
- Principal investigator: Sylvie Leroy, MD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Pauline Périnet-Marquet
- Email: p.perinet-marquet@icadom.com
- Phone: +33 7 63 23 66 15
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Galvokimig vs placebo for non-CF bronchiectasis in adults
This study tests whether Galvokimig can delay the first pulmonary flare compared with placebo in adults with non-CF bronchiectasis.
-
Safety test of HSK31858 in people with non-cystic fibrosis bronchiectasis
This phase 3 study tests whether HSK31858 is safe for adults with non-cystic fibrosis bronchiectasis who previously participated in the related study.
-
Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups
This trial tests whether taking azithromycin daily for a year reduces bronchiectasis-related flare-ups in adults with non-cystic fibrosis bronchiectasis.
-
Bronchiectasis Phenotype Identification Model for Adults
This study tests a baseline classifier to categorize adults with non-cystic fibrosis bronchiectasis into phenotype groups using data collected over time.
-
BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups
This study tests a new BASE framework to classify how severe non-cystic fibrosis bronchiectasis is right now and see if it can predict 12 months of worsening or flare-ups.
-
Nebulized CSL787 (inhaled IgG) to reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis
This research will test whether inhaled CSL787 (a nebulized immunoglobulin medicine) can delay or reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis over 6–12 months compared with placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.