Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Physio-Assist (Voir sur ClinicalTrials)
février 2025
décembre 2027
02 mars 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Benoit DOUVRY | 07/03/2025 13:43:01 | Contacter | ||
| HOPITAL FOCH | EMILIE CATHERINOT | 11/05/2026 07:26:36 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Abbeville - Abbeville 3038789 - France | Contact (sur clinicalTrials) | ||||
| CH Bretagne Atlantique - Vannes 2970777 - France | Contact (sur clinicalTrials) | ||||
| CH Compiègne-Noyon - 60200 - Compiègne 3024066 - France | Contact (sur clinicalTrials) | ||||
| CH Cotentin - Cherbourg 3025466 - France | Contact (sur clinicalTrials) | ||||
| CHRU Brest - 29200 - Brest 3030300 - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens Picardie - Amiens 3037854 - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble-Alpes - 38043 - Grenoble 3014728 - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes - 30900 - Nîmes 2990363 - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - 86021 - Poitiers 2986495 - France | Contact (sur clinicalTrials) | ||||
| CHU Reims - 51092 - Reims 2984114 - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - 35033 - Rennes 2983990 - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen - Rouen 2982652 - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse 2972315 - France | Contact (sur clinicalTrials) | ||||
| Fondation Ildys - 29684 - Roscoff 2982809 - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier du Havre - Montivilliers 2992367 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CFR Dieulefit - Dieulefit 3021397 - France | Contact (sur clinicalTrials) | ||||
| CH Aix en Provence - Aix-en-Provence 3038354 - France | Contact (sur clinicalTrials) | ||||
| CH Albi - Albi 3038261 - France | Contact (sur clinicalTrials) | ||||
| CH Alpes-Léman - 74130 - Contamine-sur-Arve 3023850 - France | Contact (sur clinicalTrials) | ||||
| CH Annecy - Annecy 3037543 - France | Contact (sur clinicalTrials) | ||||
| CH Le Puy-en-Velay - 43000 - Le Puy-en-Velay 3002465 - France | Contact (sur clinicalTrials) | ||||
| CH Libourne - 33500 - Libourne 2998517 - France | Contact (sur clinicalTrials) | ||||
| CH Pau - 64000 - Pau 2988358 - France | Contact (sur clinicalTrials) | ||||
| CH Perpignan - Perpignan 2987914 - France | Contact (sur clinicalTrials) | ||||
| CH St Quentin - Saint-Quentin 2977295 - France | Contact (sur clinicalTrials) | ||||
| CH Tarbes Lourdes - Tarbes 2973385 - France | Contact (sur clinicalTrials) | ||||
| CH Troyes - Troyes 2971549 - France | Contact (sur clinicalTrials) | ||||
| CHI Créteil - 94000 - Créteil 3022530 - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - 49033 - Angers 3037656 - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - Limoges 2998286 - France | Contact (sur clinicalTrials) | ||||
| CHU Nice - 06002 - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
| Clinique Aressy - 64320 - Aressy 3037091 - France | Contact (sur clinicalTrials) | ||||
| Clinique Victor Pauchet - 80090 - Amiens 3037854 - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier La Rochelle - Ré-Aunis - La Rochelle 3006787 - France | Contact (sur clinicalTrials) | ||||
| HCL - centre de Hyères - Hyères 3012937 - France | Contact (sur clinicalTrials) | ||||
| HCL- Hôpital Croix-Rousse - 69004 - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bicêtre (AP-HP) - 94270 - Le Kremlin-Bicêtre 3003737 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Européen de Marseille - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
| Montpellier Hospital Center - 34090 - Montpellier 2992166 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.
- 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 (Forced Vital Capacity < 60% or 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