Non-cystic Fibrosis BronchiectasisHome-BRACNCT06487273
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
A study testing SIMEOX and Remote Physiotherapy in people with Non-cystic Fibrosis Bronchiectasis, run by Physio-Assist at 57 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- SIMEOX and Remote Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 57 sitesin 6 countries
- Study dates
- 3 Feb 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 36Show fewer
- 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:
- 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);
- 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
Trial locations and contacts
57 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
57 sites in 6 countries
France41 sites, 37 recruiting
- Recruiting
CH Abbeville
Abbeville
- Recruiting
CH Aix en Provence
Aix-en-Provence
- Recruiting
CH Albi
Albi
- Recruiting
Clinique Victor Pauchet
Amiens, 80090
- Recruiting
CHU Amiens Picardie
Amiens
- Recruiting
CHU Angers
Angers, 49033
- Recruiting
CH Annecy
Annecy
- Recruiting
Clinique Aressy
Aressy, 64320
- Recruiting
CHRU Brest
Brest, 29200
- Recruiting
CH Cotentin
Cherbourg
- Recruiting
CH Compiègne-Noyon
Compiègne, 60200
- Recruiting
CH Alpes-Léman
Contamine-sur-Arve, 74130
- Recruiting
CHI Créteil
Créteil, 94000
- Recruiting
CFR Dieulefit
Dieulefit
- Recruiting
CHU Grenoble-Alpes
Grenoble, 38043
- Recruiting
HCL - centre de Hyères
Hyères
- Suspended
Groupe Hospitalier La Rochelle - Ré-Aunis
La Rochelle
- Withdrawn
Hôpital Bicêtre (AP-HP)
Le Kremlin-Bicêtre, 94270
- Recruiting
CH Le Puy-en-Velay
Le Puy-en-Velay, 43000
- Recruiting
CH Libourne
Libourne, 33500
- Recruiting
CHU Limoges
Limoges
- Recruiting
HCL- Hôpital Croix-Rousse
Lyon, 69004
- Recruiting
Hôpital Européen de Marseille
Marseille
- Withdrawn
Groupe Hospitalier du Havre
Montivilliers
- Recruiting
Montpellier Hospital Center
Montpellier, 34090
- Recruiting
CHU Nice
Nice, 06002
- Recruiting
CHU Nîmes
Nîmes, 30900
- Recruiting
Hôpital Cochin (AP-HP)
Paris, 75014
- Recruiting
CH Pau
Pau, 64000
- Not yet recruiting
CH Perpignan
Perpignan
- Recruiting
CHU Poitiers
Poitiers, 86021
- Recruiting
CHU Reims
Reims, 51092
- Recruiting
CHU Rennes
Rennes, 35033
- Recruiting
Fondation Ildys
Roscoff, 29684
- Withdrawn
CHU Rouen
Rouen
- Recruiting
CH St Quentin
Saint-Quentin
- Recruiting
Hôpital Foch
Suresnes
- Recruiting
CH Tarbes Lourdes
Tarbes
- Recruiting
CHU Toulouse
Toulouse
- Recruiting
CH Troyes
Troyes
- Recruiting
CH Bretagne Atlantique
Vannes
United Kingdom5 sites, 5 recruiting
- Recruiting
Royal Victoria Hospital, Belfast Health and Social Care Trust
Belfast, BT12 6BA
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Not yet recruiting
Royal Papworth Hospital, NHS Foundation Trust
Cambridge, CB2 0AY
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent/morin@inogen.net
- Recruiting
NHS Lothian
Edinburgh, EH3 9DN
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Recruiting
Royal Brompton & Harefield Hospitals, Guy's & St Thomas' NHS Foundation Trust
London, SW3 6NP
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
Germany3 sites, 3 recruiting
- Recruiting
Medizinische Klinik V University hospital
Aachen, 52074
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Recruiting
LMU Klinikum
München, 80336
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogne.net
Poland3 sites, 3 recruiting
- Not yet recruiting
Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Recruiting
Uniwersytet Medyczny w Łodzi Nr 1 im. Norberta Barlickiego
Lodz, 90-153
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Not yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-355
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
Portugal3 sites, 3 recruiting
- Not yet recruiting
Centro Clínico Académico de Braga (2CA-Braga) ULS de Braga
Braga, 4710-243
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Not yet recruiting
Hospital Senhora de Oliveira Guimarães ULS Alto Ave
Creixomil, 4835-044
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
- Not yet recruiting
Instituto CUF
Porto, 4460-188
Typhaine Pierre, +33618746394, typhaine.pierre@clinact.com
Laurent MORIN, +33603273012, laurent.morin@inogen.net
Reunion2 sites, 2 recruiting
- Recruiting
CHU La Réunion Félix Guyon
Saint-Denis
- Recruiting
CHU La Réunion Sud
Saint-Pierre
About this study
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
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.
Read more
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).
Read the detailed description
Two main objectives will be assessed sequentially:
- To compare the effect of SIMEOX, combined with remote Physiotherapy with enhanced SoC (SoC + Remote Physiotherapy) on the rate of respiratory exacerbations at long term.
- To compare the effect of SIMEOX, combined with remote Physiotherapy, with enhanced SoC (SoC + Remote Physiotherapy), on the quality of life related to the respiratory problems of patients at mid term.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- SIMEOX, Remote Physiotherapy
- Keywords
- Non-CF Bronchiectasis, Bronchial clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMEOXDevice
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).
Remote PhysiotherapyOther
Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Remote Physiotherapy + standard of care Receives: Other: Remote Physiotherapy |
| SIMEOX | Experimental | SIMEOX device combined with Remote Physiotherapy + standard of care Receives: Device: SIMEOX; Other: Remote Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Over the duration of the study (24 months in average)
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.
Measured: Change from baseline at 6 months
Secondary outcomes (47)
Quality of life SGRQ at 12 months
The change in total quality of life score measured by the St George's Respiratory Questionnaire from baseline at 12 months of treatment, adjusted for the baseline score, will be compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 12 months
Quality of life SGRQ at 24 months
The change in total quality of life score measured by the St George's Respiratory Questionnaire from baseline at 24 months of treatment, adjusted for the baseline score, will be compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 24 months
3 domains of quality of life of the SGRQ at 6 months
The change in scores of any of the 3 domains of quality of life of the St George's Respiratory Questionnaire from baseline at 6 months of treatment, adjusted for the score at inclusion, compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 6 months
3 domains of quality of life of the SGRQ at 12 months
The change in scores of any of the 3 domains of quality of life of the St George's Respiratory Questionnaire from baseline at 12 months of treatment, adjusted for the score at inclusion, compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 12 months
3 domains of quality of life of the SGRQ at 24 months
The change in scores of any of the 3 domains of quality of life of the St George's Respiratory Questionnaire from baseline at 24 months of treatment, adjusted for the score at inclusion, compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 24 months
QoL-B questionnaire at 6 months
The change in specific quality of life measured by the QoL-B questionnaire (8 domains) from baseline at 6 months of treatment, adjusted on the baseline score, compared between the SIMEOX-treated group and the control group
Measured: Change from baseline at 6 months
QoL-B questionnaire at 12 months
The change in specific quality of life measured by the QoL-B questionnaire (8 domains) from baseline at 12 months of treatment, adjusted on the baseline score, compared between the SIMEOX-treated group and the control group
Measured: Change from baseline at 12 months
QoL-B questionnaire at 24 months
The change in specific quality of life measured by the QoL-B questionnaire (8 domains) from baseline at 24 months of treatment, adjusted on the baseline score, compared between the SIMEOX-treated group and the control group
Measured: Change from baseline at 24 months
EQ5D-5L questionnaire at 6 months
The change in global quality of life measured by the EuroQol 5 D descriptive system-5 Level questionnaire (EQ5D-5L) from baseline at 6 months of treatment, adjusted on the baseline score, compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 6 months
EQ5D-5L questionnaire at 12 months
The change in global quality of life measured by the EQ5D-5L questionnaire from baseline at 12 months of treatment, adjusted on the baseline score, compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 12 months
EQ5D-5L questionnaire at 24 months
The change in global quality of life measured by the EQ5D-5L questionnaire from baseline at 24 months of treatment, adjusted on the baseline score, compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 24 months
CAAT questionnaire at 6 months
The change in the perception of respiratory health measured by the Chronic Airways Assessment Test (CAAT) questionnaire from baseline at 6 months of treatment, adjusted on the baseline score, will be compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 6 months
CAAT questionnaire at 12 months
The change in the perception of respiratory health measured by the Chronic Airways Assessment Test (CAAT) questionnaire from baseline at 12 months of treatment, adjusted on the baseline score, will be compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 12 months
CAAT questionnaire at 24 months
The change in the perception of respiratory health measured by the Chronic Airways Assessment Test (CAAT) questionnaire from baseline at 24 months of treatment, adjusted on the baseline score, will be compared between the SIMEOX-treated group and the control group.
Measured: Change from baseline at 24 months
spirometry parameters : FEV1 at 6 months
The change of the Forced expiratory volume in 1 second (FEV1) spirometry parameter of the respiratory function from inclusion at 6 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 6 months
spirometry parameters : FEV1 at 12 months
The change of the FEV1 spirometry parameter of the respiratory function from inclusion at 12 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 12 months
spirometry parameters : FEV1 at 24 months
The change of the FEV1 spirometry parameter of the respiratory function from inclusion at 24 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 24 months
spirometry parameters : FVC at 6 months
The change of the Forced vital capacity (FVC) spirometry parameter of the respiratory function from inclusion at 6 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 6 months
spirometry parameters : FVC at 12 months
The change of the FVC spirometry parameter of the respiratory function from inclusion at 12 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 12 months
spirometry parameters : FVC at 24 months
The change of the FVC spirometry parameter of the respiratory function from inclusion at 24 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 24 months
spirometry parameters : FEV1/FVC at 6 months
The change of the FEV1/FVC spirometry parameter of the respiratory function from inclusion at 6 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 6 months
spirometry parameters : FEV1/FVC at 12 months
The change of the FEV1/FVC spirometry parameter of the respiratory function from inclusion at 12 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 12 months
spirometry parameters : FEV1/FVC at 24 months
The change of the FEV1/FVC spirometry parameter of the respiratory function from inclusion at 24 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 24 months
spirometry parameters : FEF 25-75% at 6 months
The change of the Forced mid-expiratory flow rate between 25% and 75% of the vital capacity (FEF 25-75%) spirometry parameter from inclusion at 6 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 6 months
spirometry parameters : FEF 25-75% at 12 months
The change of the FEF 25-75% spirometry parameter of the respiratory function from inclusion at 12 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 12 months
spirometry parameters : FEF 25-75% at 24 months
The change of the FEF 25-75% spirometry parameter of the respiratory function from inclusion at 24 months of treatment, adjusted on the baseline values, compared between the SIMEOX-treated group and the control group.
Measured: Change from inclusion at 24 months
Time period before first exacerbation
The time period, in days, between the date of randomisation and the start of the first respiratory exacerbation (as defined in the main co-criterion) compared between the SIMEOX-treated group and the control group
Measured: Over the duration of the study (24 months in average)
Rate of respiratory exacerbations with hospitalisation at 6 months
The rate of respiratory exacerbations (as defined in the main co-criterion) with hospitalisation observed per patient per year at 6 months of treatment, compared between the SIMEOX-treated group and the control group.
Hospitalisations will be documented according to whether the patient is admitted in conventional care or intensive care/resuscitation.
Measured: 6 months
Rate of respiratory exacerbations with hospitalisation at 12 months
The rate of respiratory exacerbations (as defined in the main co-criterion) with hospitalisation observed per patient per year at 12 months of treatment, compared between the SIMEOX-treated group and the control group.
Hospitalisations will be documented according to whether the patient is admitted in conventional care or intensive care/resuscitation.
Measured: 12 months
Rate of respiratory exacerbations with hospitalisation over the duration of the study
The rate of respiratory exacerbations (as defined in the main co-criterion) with hospitalisation observed per patient per year over the duration of the study (24 months in average), compared between the SIMEOX-treated group and the control group.
Hospitalisations will be documented according to whether the patient is admitted in conventional care or intensive care/resuscitation.
Measured: Over the duration of the study (24 months in average)
Rate of respiratory exacerbations without hospitalisation at 6 months
The rate of respiratory exacerbations (as defined in the main co-criterion) without hospitalisation observed per patient per year at 6 months of treatment, compared between the SIMEOX-treated group and the control group.
Hospitalisations will be documented according to whether the patient is admitted in conventional care or intensive care/resuscitation.
Measured: 6 months
Rate of respiratory exacerbations without hospitalisation at 12 months
The rate of respiratory exacerbations (as defined in the main co-criterion) without hospitalisation observed per patient per year at 12 months of treatment, compared between the SIMEOX-treated group and the control group.
Hospitalisations will be documented according to whether the patient is admitted in conventional care or intensive care/resuscitation.
Measured: 12 months
Rate of respiratory exacerbations without hospitalisation over the duration of the study
The rate of respiratory exacerbations (as defined in the main co-criterion) without hospitalisation observed per patient per year over the duration of the study (24 months in average), compared between the SIMEOX-treated group and the control group.
Hospitalisations will be documented according to whether the patient is admitted in conventional care or intensive care/resuscitation.
Measured: Over the duration of the study (24 months in average)
Proportion of patients with 2 or more exacerbations at 6 months
The proportion of patients with 2 or more exacerbations observed at 6 months of treatment will be compared between the SIMEOX-treated group and the control group.
Measured: 6 months
Proportion of patients with 2 or more exacerbations at 12 months
The proportion of patients with 2 or more exacerbations observed at 12 months of treatment will be compared between the SIMEOX-treated group and the control group.
Measured: 12 months
Proportion of patients with 2 or more exacerbations over the duration of the study
The proportion of patients with 2 or more exacerbations observed over the duration of the study will be compared between the SIMEOX-treated group and the control group.
Measured: Over the duration of the study (24 months in average)
Proportion of patients with at least one hospitalisation for exacerbations at 6 months
The proportion of patients with at least one hospitalisation for exacerbations observed at 6 months of treatment will be compared between the SIMEOX-treated group and the control group.
Measured: 6 months
Proportion of patients with at least one hospitalisation for exacerbations at 12 months
The proportion of patients with at least one hospitalisation for exacerbations observed at 12 months of treatment will be compared between the SIMEOX-treated group and the control group.
Measured: 12 months
Proportion of patients with at least one hospitalisation for exacerbations over the duration of the study
The proportion of patients with at least one hospitalisation for exacerbations observed over the duration of the study will be compared between the SIMEOX-treated group and the control group.
Measured: Over the duration of the study (24 months in average)
Duration of hospitalisation for exacerbations at 6 months
The duration of hospitalisation for exacerbations observed at 6 months of treatment will be compared between the SIMEOX-treated group and the control group.
Measured: 6 months
Duration of hospitalisation for exacerbations at 12 months
The duration of hospitalisation for exacerbations observed at 12 months of treatment will be compared between the SIMEOX-treated group and the control group.
Measured: 12 months
Duration of hospitalisation for exacerbations over the duration of the study
The duration of hospitalisation for exacerbations observed over the duration of the study will be compared between the SIMEOX-treated group and the control group.
Measured: Over the duration of the study (24 months in average)
The percentage of responder / non-responder patients at 12 months
The percentage of responder / non-responder patients from inclusion at 12 months of treatment will be assessed by:
- a change in St George's Hospital Respiratory Questionnaire (SGRQ) total quality of life score greater than minimal clinically important difference (MCID) (> or equal to 4 points), and/or
- the absence of pulmonary exacerbation during this period.
Patients belonging to the other categories (SGRQ variation < 4 and presence of one or more pulmonary exacerbations) will be classified as non-responders at 12 months of treatment.
Measured: 12 months
The percentage of responder / non-responder patients at 24 months
The percentage of responder / non-responder patients patients from inclusion at 24 months of treatment, will be assessed by:
- a change in St George's Hospital Respiratory Questionnaire (SGRQ) total quality of life score greater than MCID (> or equal to 4 points), and/or
- the absence of pulmonary exacerbation during this period.
Patients belonging to the other categories (SGRQ variation < 4 and presence of one or more pulmonary exacerbations) will be classified as non-responders at 24 months of treatment.
Measured: 24 months
Average number of sessions
Changes in adherence to the SIMEOX device will be described by the average number of sessions performed by the patient over the entire follow-up period and for each month/quarter of participation
Measured: Over the duration of the study (24 months in average)
Proportion of compliant patients
The proportion of compliant patients will be evaluated by the percentage of patients having performed 3 sessions or more per week over the entire follow-up period and for each quarter (SIMEOX group only).
Measured: Over the duration of the study (24 months in average)
Number of adverse events
Safety of use will be assessed by the number of adverse events related to the procedure for using the medical device or to the medical device itself over the course of the study (24 months in average). These will be counted and qualified as serious or non-serious.
Measured: Over the duration of the study (24 months in average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start3 Feb 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physio-Assist
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom, Clinact
- Responsible party
- Sponsor
- Investigators
- Sylvie Leroy, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487273
- Sponsor's protocol ID
- 2023-A01095-40
- Acronym
- Home-BRAC
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37524523
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06487273
- Acronym / sponsor ID
- Home-BRAC / 2023-A01095-40
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- Non-CF Bronchiectasis, Bronchial clearance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Physio-AssistIndustry (pharma, biotech, devices)
- Collaborators
- Icadom, Clinact
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Two main objectives will be assessed sequentially:
- To compare the effect of SIMEOX, combined with remote Physiotherapy with enhanced SoC (SoC + Remote Physiotherapy) on the rate of respiratory exacerbations at long term.
- To compare the effect of SIMEOX, combined with remote Physiotherapy, with enhanced SoC (SoC + Remote Physiotherapy), on the quality of life related to the respiratory problems of patients at mid term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Remote PhysiotherapyRemote Physiotherapy + standard of care |
| SIMEOX | Experimental | Device: SIMEOX, Other: Remote PhysiotherapySIMEOX device combined with Remote Physiotherapy + standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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.
Key exclusion criteria (36 listed)
- Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion:
- Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIMEOXUse 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). | Device | SIMEOX |
| Remote PhysiotherapyRemote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after | Other | Control, SIMEOX |
Primary outcome
The annual rate of pulmonary exacerbations
Time frame: Over the duration of the study (24 months in average)
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).
Quality of life SGRQ at 6 months
Time frame: Change from baseline 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.
47 secondary outcomes
Quality of life SGRQ at 12 months
Time frame: Change from baseline at 12 months
Quality of life SGRQ at 24 months
Time frame: Change from baseline at 24 months
3 domains of quality of life of the SGRQ at 6 months
Time frame: Change from baseline at 6 months
3 domains of quality of life of the SGRQ at 12 months
Time frame: Change from baseline at 12 months
3 domains of quality of life of the SGRQ at 24 months
Time frame: Change from baseline at 24 months
QoL-B questionnaire at 6 months
Time frame: Change from baseline at 6 months
QoL-B questionnaire at 12 months
Time frame: Change from baseline at 12 months
QoL-B questionnaire at 24 months
Time frame: Change from baseline at 24 months
EQ5D-5L questionnaire at 6 months
Time frame: Change from baseline at 6 months
EQ5D-5L questionnaire at 12 months
Time frame: Change from baseline at 12 months
EQ5D-5L questionnaire at 24 months
Time frame: Change from baseline at 24 months
CAAT questionnaire at 6 months
Time frame: Change from baseline at 6 months
CAAT questionnaire at 12 months
Time frame: Change from baseline at 12 months
CAAT questionnaire at 24 months
Time frame: Change from baseline at 24 months
spirometry parameters : FEV1 at 6 months
Time frame: Change from inclusion at 6 months
spirometry parameters : FEV1 at 12 months
Time frame: Change from inclusion at 12 months
spirometry parameters : FEV1 at 24 months
Time frame: Change from inclusion at 24 months
spirometry parameters : FVC at 6 months
Time frame: Change from inclusion at 6 months
spirometry parameters : FVC at 12 months
Time frame: Change from inclusion at 12 months
spirometry parameters : FVC at 24 months
Time frame: Change from inclusion at 24 months
spirometry parameters : FEV1/FVC at 6 months
Time frame: Change from inclusion at 6 months
spirometry parameters : FEV1/FVC at 12 months
Time frame: Change from inclusion at 12 months
spirometry parameters : FEV1/FVC at 24 months
Time frame: Change from inclusion at 24 months
spirometry parameters : FEF 25-75% at 6 months
Time frame: Change from inclusion at 6 months
spirometry parameters : FEF 25-75% at 12 months
Time frame: Change from inclusion at 12 months
spirometry parameters : FEF 25-75% at 24 months
Time frame: Change from inclusion at 24 months
Time period before first exacerbation
Time frame: Over the duration of the study (24 months in average)
Rate of respiratory exacerbations with hospitalisation at 6 months
Time frame: 6 months
Rate of respiratory exacerbations with hospitalisation at 12 months
Time frame: 12 months
Rate of respiratory exacerbations with hospitalisation over the duration of the study
Time frame: Over the duration of the study (24 months in average)
Rate of respiratory exacerbations without hospitalisation at 6 months
Time frame: 6 months
Rate of respiratory exacerbations without hospitalisation at 12 months
Time frame: 12 months
Rate of respiratory exacerbations without hospitalisation over the duration of the study
Time frame: Over the duration of the study (24 months in average)
Proportion of patients with 2 or more exacerbations at 6 months
Time frame: 6 months
Proportion of patients with 2 or more exacerbations at 12 months
Time frame: 12 months
Proportion of patients with 2 or more exacerbations over the duration of the study
Time frame: Over the duration of the study (24 months in average)
Proportion of patients with at least one hospitalisation for exacerbations at 6 months
Time frame: 6 months
Proportion of patients with at least one hospitalisation for exacerbations at 12 months
Time frame: 12 months
Proportion of patients with at least one hospitalisation for exacerbations over the duration of the study
Time frame: Over the duration of the study (24 months in average)
Duration of hospitalisation for exacerbations at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 37524523Hamidfar 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.
- Individual participant dataSharing planned: No
Related trials for Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvie Leroy, MD principal investigator
Centre Hospitalier Universitaire de Nice
57 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMEOX and Remote Physiotherapy in people with Non-cystic Fibrosis Bronchiectasis, run by Physio-Assist at 57 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in France, United Kingdom, Germany, Poland, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Périnet-Marquet (+33 7 63 23 66 15, p.perinet-marquet@icadom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The annual rate of pulmonary exacerbations (time frame: Over the duration of the study (24 months in average)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.