Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
NCT Number: NCT06487273
Acronym: Home-BRAC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-cystic Fibrosis Bronchiectasis
Interventions: DEVICE: SIMEOX|OTHER: Remote Physiotherapy
Sponsor: Physio-Assist
Collaborators: Icadom|Clinact
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 622
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12
Locations: CH Aix en Provence, Aix-en-Provence, France|Clinique Victor Pauchet, Amiens, 80090, France|CHU Amiens Picardie, Amiens, France|CHU Angers, Angers, 49033, France|CHRU Brest, Brest, 29200, France|CH Compiègne-Noyon, Compiègne, 60200, France|CH Alpes-Léman, Contamine-sur-Arve, 74130, France|CHI Créteil, Créteil, 94000, France|CHU Grenoble-Alpes, Grenoble, 38043, France|Groupe Hospitalier La Rochelle - Ré-Aunis, La Rochelle, France|Hôpital Bicêtre (AP-HP), Le Kremlin-Bicêtre, 94270, France|CH Le Puy-en-Velay, Le Puy-en-Velay, 43000, France|CH Libourne, Libourne, 33500, France|HCL- Hôpital Croix-Rousse, Lyon, 69004, France|Groupe Hospitalier du Havre, Montivilliers, France|Montpellier Hospital Center, Montpellier, 34090, France|CHU Nice, Nice, 06002, France|CHU Nîmes, Nîmes, 30900, France|Hôpital Cochin (AP-HP), Paris, 75014, France|CH Pau, Pau, 64000, France|CHU Poitiers, Poitiers, 86021, France|CHU Reims, Reims, 51092, France|CHU Rennes, Rennes, 35033, France|Fondation Ildys, Roscoff, 29684, France|CHU Rouen, Rouen, France|Hôpital Foch, Suresnes, France|CH Tarbes Lourdes, Tarbes, France|CHU Toulouse, Toulouse, France|CH Troyes, Troyes, France|CH Bretagne Atlantique, Vannes, France|CHU La Réunion Félix Guyon, Saint-Denis, Réunion|CHU La Réunion Sud, Saint-Pierre, Réunion

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. 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).

Primary Outcome Measures: 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., Change from baseline at 6 months|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)., Over the duration of the study (24 months in average)
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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, 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, 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, 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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, 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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, 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)., 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., Over the duration of the study (24 months in average)