Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis (Home-BRAC)

April 20, 2026 updated by: Physio-Assist

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Two main objectives will be assessed simultaneously:

  • 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.
  • 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.

Study Type

Interventional

Enrollment (Estimated)

622

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Abbeville, France
        • Recruiting
        • CH Abbeville
      • Aix-en-Provence, France
        • Recruiting
        • CH Aix en Provence
      • Albi, France
        • Recruiting
        • CH ALBI
      • Amiens, France
        • Recruiting
        • CHU Amiens Picardie
      • Amiens, France, 80090
        • Recruiting
        • Clinique Victor Pauchet
      • Angers, France, 49033
        • Recruiting
        • CHU Angers
      • Annecy, France
        • Recruiting
        • CH Annecy
      • Aressy, France, 64320
        • Not yet recruiting
        • Clinique Aressy
      • Brest, France, 29200
        • Recruiting
        • CHRU Brest
      • Cherbourg, France
        • Recruiting
        • CH Cotentin
      • Compiègne, France, 60200
        • Recruiting
        • CH Compiègne-Noyon
      • Contamine-sur-Arve, France, 74130
        • Recruiting
        • CH Alpes-Léman
      • Créteil, France, 94000
        • Recruiting
        • Chi Creteil
      • Dieulefit, France
        • Recruiting
        • CFR Dieulefit
      • Grenoble, France, 38043
        • Recruiting
        • CHU Grenoble-Alpes
      • Hyères, France
        • Recruiting
        • HCL - centre de Hyères
      • La Rochelle, France
        • Suspended
        • Groupe Hospitalier La Rochelle - Ré-Aunis
      • Le Kremlin-Bicêtre, France, 94270
        • Withdrawn
        • Hôpital Bicêtre (AP-HP)
      • Le Puy-en-Velay, France, 43000
        • Recruiting
        • CH Le Puy-en-Velay
      • Libourne, France, 33500
        • Recruiting
        • CH Libourne
      • Limoges, France
        • Recruiting
        • CHU Limoges
      • Lyon, France, 69004
        • Recruiting
        • HCL- Hôpital Croix-Rousse
      • Marseille, France
        • Recruiting
        • Hôpital Européen de Marseille
      • Montivilliers, France
        • Not yet recruiting
        • Groupe Hospitalier Du Havre
      • Montpellier, France, 34090
        • Recruiting
        • Montpellier Hospital Center
      • Nice, France, 06002
        • Recruiting
        • CHU Nice
      • Nîmes, France, 30900
        • Recruiting
        • CHU Nîmes
      • Paris, France, 75014
        • Recruiting
        • Hôpital Cochin (AP-HP)
      • Pau, France, 64000
        • Recruiting
        • CH PAU
      • Perpignan, France
        • Not yet recruiting
        • CH Perpignan
      • Poitiers, France, 86021
        • Not yet recruiting
        • CHU Poitiers
      • Reims, France, 51092
        • Recruiting
        • Chu Reims
      • Rennes, France, 35033
        • Recruiting
        • Chu Rennes
      • Roscoff, France, 29684
        • Recruiting
        • Fondation Ildys
      • Rouen, France
        • Not yet recruiting
        • CHU Rouen
      • Saint-Quentin, France
        • Recruiting
        • CH St Quentin
      • Suresnes, France
        • Recruiting
        • Hopital Foch
      • Tarbes, France
        • Recruiting
        • CH Tarbes Lourdes
      • Toulouse, France
        • Recruiting
        • CHU Toulouse
      • Troyes, France
        • Recruiting
        • Ch Troyes
      • Vannes, France
        • Recruiting
        • CH Bretagne Atlantique
  • Germany
      • Aachen, Germany, 52074
      • Lübeck, Germany, 23538
      • München, Germany, 80336
        • Active, not recruiting
        • LMU Klinikum
  • Poland
      • Krakow, Poland, 30-688
      • Lodz, Poland, 90-153
      • Poznan, Poland, 60-355
  • Portugal
      • Braga, Portugal, 4710-243
      • Creixomil, Portugal, 4835-044
      • Porto, Portugal, 4460-188
  • Reunion
      • Saint-Denis, Reunion
        • Recruiting
        • CHU La Réunion Félix Guyon
      • Saint-Pierre, Reunion
        • Recruiting
        • CHU La Réunion Sud
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
      • Birmingham, United Kingdom, B9 5SS
        • Not yet recruiting
        • Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust
        • Contact:
        • Contact:
      • Edinburgh, United Kingdom, EH3 9DN
      • Manchester, United Kingdom, M23 9LT
        • Not yet recruiting
        • Wythenshawe Hospital, Manchester University, NHS Foundation Trust
        • Contact:
        • Contact:
      • Newcastle upon Tyne, United Kingdom, NE7 7DN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Remote Physiotherapy + standard of care
Other: Remote Physiotherapy
Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
Experimental: SIMEOX
SIMEOX device combined with Remote Physiotherapy + standard of care
Other: Remote Physiotherapy
Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
Device: SIMEOX
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 6 months
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).
Over the duration of the study (24 months in average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life SGRQ at 12 months
Time Frame: Change from baseline 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.
Change from baseline at 12 months
Quality of life SGRQ at 24 months
Time Frame: Change from baseline 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.
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
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.
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
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.
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
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.
Change from baseline at 24 months
QoL-B questionnaire at 6 months
Time Frame: Change from baseline 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
Change from baseline at 6 months
QoL-B questionnaire at 12 months
Time Frame: Change from baseline 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
Change from baseline at 12 months
QoL-B questionnaire at 24 months
Time Frame: Change from baseline 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
Change from baseline at 24 months
EQ5D-5L questionnaire at 6 months
Time Frame: Change from baseline 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.
Change from baseline at 6 months
EQ5D-5L questionnaire at 12 months
Time Frame: Change from baseline 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.
Change from baseline at 12 months
EQ5D-5L questionnaire at 24 months
Time Frame: Change from baseline 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.
Change from baseline at 24 months
CAAT questionnaire at 6 months
Time Frame: Change from baseline 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.
Change from baseline at 6 months
CAAT questionnaire at 12 months
Time Frame: Change from baseline 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.
Change from baseline at 12 months
CAAT questionnaire at 24 months
Time Frame: Change from baseline 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.
Change from baseline at 24 months
spirometry parameters : FEV1 at 6 months
Time Frame: Change from inclusion 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.
Change from inclusion at 6 months
spirometry parameters : FEV1 at 12 months
Time Frame: Change from inclusion 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.
Change from inclusion at 12 months
spirometry parameters : FEV1 at 24 months
Time Frame: Change from inclusion 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.
Change from inclusion at 24 months
spirometry parameters : FVC at 6 months
Time Frame: Change from inclusion 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.
Change from inclusion at 6 months
spirometry parameters : FVC at 12 months
Time Frame: Change from inclusion 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.
Change from inclusion at 12 months
spirometry parameters : FVC at 24 months
Time Frame: Change from inclusion 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.
Change from inclusion at 24 months
spirometry parameters : FEV1/FVC at 6 months
Time Frame: Change from inclusion 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.
Change from inclusion at 6 months
spirometry parameters : FEV1/FVC at 12 months
Time Frame: Change from inclusion 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.
Change from inclusion at 12 months
spirometry parameters : FEV1/FVC at 24 months
Time Frame: Change from inclusion 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.
Change from inclusion at 24 months
spirometry parameters : FEF 25-75% at 6 months
Time Frame: Change from inclusion 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.
Change from inclusion at 6 months
spirometry parameters : FEF 25-75% at 12 months
Time Frame: Change from inclusion 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.
Change from inclusion at 12 months
spirometry parameters : FEF 25-75% at 24 months
Time Frame: Change from inclusion 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.
Change from inclusion at 24 months
Time period before first exacerbation
Time Frame: Over the duration of the study (24 months in average)
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
Over the duration of the study (24 months in average)
Rate of respiratory exacerbations with hospitalisation at 6 months
Time Frame: 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.
6 months
Rate of respiratory exacerbations with hospitalisation at 12 months
Time Frame: 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.
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)

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.
Over the duration of the study (24 months in average)
Rate of respiratory exacerbations without hospitalisation at 6 months
Time Frame: 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.
6 months
Rate of respiratory exacerbations without hospitalisation at 12 months
Time Frame: 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.
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)

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.
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
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.
6 months
Proportion of patients with 2 or more exacerbations at 12 months
Time Frame: 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.
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)
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.
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
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.
6 months
Proportion of patients with at least one hospitalisation for exacerbations at 12 months
Time Frame: 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.
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)
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.
Over the duration of the study (24 months in average)
Duration of hospitalisation for exacerbations at 6 months
Time Frame: 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.
6 months
Duration of hospitalisation for exacerbations at 12 months
Time Frame: 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.
12 months
Duration of hospitalisation for exacerbations over the duration of the study
Time Frame: Over the duration of the study (24 months in average)
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.
Over the duration of the study (24 months in average)
The percentage of responder / non-responder patients at 12 months
Time Frame: 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.
12 months
The percentage of responder / non-responder patients at 24 months
Time Frame: 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.
24 months
Average number of sessions
Time Frame: Over the duration of the study (24 months in average)
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
Over the duration of the study (24 months in average)
Proportion of compliant patients
Time Frame: Over the duration of the study (24 months in average)
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).
Over the duration of the study (24 months in average)
Number of adverse events
Time Frame: Over the duration of the study (24 months in average)
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.
Over the duration of the study (24 months in average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physio-Assist

Collaborators

Icadom
Clinact

Investigators

  • Principal Investigator: Sylvie Leroy, MD, CHU Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01095-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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