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 (Home-BRAC)
Interventional
N/A
Physio-Assist (Voir sur ClinicalTrials)
février 2025
décembre 2027
04 avril 2025
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 | 05/05/2025 07:12:15 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Abbeville - Abbeville - France | Contact (sur clinicalTrials) | ||||
| CH Aix en Provence - Aix-en-Provence - France | Contact (sur clinicalTrials) | ||||
| CH Alpes-Léman - 74130 - Contamine-sur-Arve - France | Contact (sur clinicalTrials) | ||||
| CH Bretagne Atlantique - Vannes - France | Contact (sur clinicalTrials) | ||||
| CH Compiègne - Compiègne - France | Contact (sur clinicalTrials) | ||||
| CH Compiègne-Noyon - 60200 - Compiègne - France | Contact (sur clinicalTrials) | ||||
| CH Le Puy-en-Velay - 43000 - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| CH Libourne - 33500 - Libourne - France | Contact (sur clinicalTrials) | ||||
| CH Pau - 64000 - Pau - France | Contact (sur clinicalTrials) | ||||
| CH Tarbes Lourdes - Tarbes - France | Contact (sur clinicalTrials) | ||||
| CH Troyes - Troyes - France | Contact (sur clinicalTrials) | ||||
| CHI Créteil - 94000 - Créteil - France | Contact (sur clinicalTrials) | ||||
| CHRU Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens Picardie - Amiens - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - 49033 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble-Alpes - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU Nice - 06002 - Nice - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes - 30900 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU Reims - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique Victor Pauchet - 80090 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Fondation Ildys - 29684 - Roscoff - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier du Havre - Montivilliers - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier La Rochelle - Ré-Aunis - La Rochelle - France | Contact (sur clinicalTrials) | ||||
| HCL- Hôpital Croix-Rousse - 69004 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bicêtre (AP-HP) - 94270 - Le Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| Hôpital Foch - Suresnes - France | Contact (sur clinicalTrials) | ||||
| Montpellier Hospital Center - 34090 - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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