Clinical trial NCT06487273: Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-cystic Fibrosis Bronchiectasis
Keywords: Non-CF Bronchiectasis
Bronchial clearance
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
Collaborators: name: Icadom
name: Clinact
First posted: 2024-07-05
Enrollment: 622
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life SGRQ at 6 months
timeFrame: Change from baseline at 6 months
measure: The annual rate of pulmonary exacerbations
timeFrame: Over the duration of the study (24 months in average)
Secondary outcomes:
measure: Quality of life SGRQ at 12 months
timeFrame: Change from baseline at 12 months
measure: Quality of life SGRQ at 24 months
timeFrame: Change from baseline at 24 months
measure: 3 domains of quality of life of the SGRQ at 6 months
timeFrame: Change from baseline at 6 months
measure: 3 domains of quality of life of the SGRQ at 12 months
timeFrame: Change from baseline at 12 months
measure: 3 domains of quality of life of the SGRQ at 24 months
timeFrame: Change from baseline at 24 months
measure: QoL-B questionnaire at 6 months
timeFrame: Change from baseline at 6 months
measure: QoL-B questionnaire at 12 months
timeFrame: Change from baseline at 12 months
measure: QoL-B questionnaire at 24 months
timeFrame: Change from baseline at 24 months
measure: EQ5D-5L questionnaire at 6 months
timeFrame: Change from baseline at 6 months
measure: EQ5D-5L questionnaire at 12 months
timeFrame: Change from baseline at 12 months
measure: EQ5D-5L questionnaire at 24 months
timeFrame: Change from baseline at 24 months
measure: CAAT questionnaire at 6 months
timeFrame: Change from baseline at 6 months
measure: CAAT questionnaire at 12 months
timeFrame: Change from baseline at 12 months
measure: CAAT questionnaire at 24 months
timeFrame: Change from baseline at 24 months
measure: spirometry parameters : FEV1 at 6 months
timeFrame: Change from inclusion at 6 months
measure: spirometry parameters : FEV1 at 12 months
timeFrame: Change from inclusion at 12 months
measure: spirometry parameters : FEV1 at 24 months
timeFrame: Change from inclusion at 24 months
measure: spirometry parameters : FVC at 6 months
timeFrame: Change from inclusion at 6 months
measure: spirometry parameters : FVC at 12 months
timeFrame: Change from inclusion at 12 months
measure: spirometry parameters : FVC at 24 months
timeFrame: Change from inclusion at 24 months
measure: spirometry parameters : FEV1/FVC at 6 months
timeFrame: Change from inclusion at 6 months
measure: spirometry parameters : FEV1/FVC at 12 months
timeFrame: Change from inclusion at 12 months
measure: spirometry parameters : FEV1/FVC at 24 months
timeFrame: Change from inclusion at 24 months
measure: spirometry parameters : FEF 25-75% at 6 months
timeFrame: Change from inclusion at 6 months
measure: spirometry parameters : FEF 25-75% at 12 months
timeFrame: Change from inclusion at 12 months
measure: spirometry parameters : FEF 25-75% at 24 months
timeFrame: Change from inclusion at 24 months
measure: Time period before first exacerbation
timeFrame: Over the duration of the study (24 months in average)
measure: Rate of respiratory exacerbations with hospitalisation at 6 months
timeFrame: 6 months
measure: Rate of respiratory exacerbations with hospitalisation at 12 months
timeFrame: 12 months
measure: Rate of respiratory exacerbations with hospitalisation over the duration of the study
timeFrame: Over the duration of the study (24 months in average)
measure: Rate of respiratory exacerbations without hospitalisation at 6 months
timeFrame: 6 months
measure: Rate of respiratory exacerbations without hospitalisation at 12 months
timeFrame: 12 months
measure: Rate of respiratory exacerbations without hospitalisation over the duration of the study
timeFrame: Over the duration of the study (24 months in average)
measure: Proportion of patients with 2 or more exacerbations at 6 months
timeFrame: 6 months
measure: Proportion of patients with 2 or more exacerbations at 12 months
timeFrame: 12 months
measure: Proportion of patients with 2 or more exacerbations over the duration of the study
timeFrame: Over the duration of the study (24 months in average)
measure: Proportion of patients with at least one hospitalisation for exacerbations at 6 months
timeFrame: 6 months
measure: Proportion of patients with at least one hospitalisation for exacerbations at 12 months
timeFrame: 12 months
measure: Proportion of patients with at least one hospitalisation for exacerbations over the duration of the study
timeFrame: Over the duration of the study (24 months in average)
measure: Duration of hospitalisation for exacerbations at 6 months
timeFrame: 6 months
measure: Duration of hospitalisation for exacerbations at 12 months
timeFrame: 12 months
measure: Duration of hospitalisation for exacerbations over the duration of the study
timeFrame: Over the duration of the study (24 months in average)
measure: The percentage of responder / non-responder patients at 12 months
timeFrame: 12 months
measure: The percentage of responder / non-responder patients at 24 months
timeFrame: 24 months
measure: Average number of sessions
timeFrame: Over the duration of the study (24 months in average)
measure: Proportion of compliant patients
timeFrame: Over the duration of the study (24 months in average)
measure: Number of adverse events
timeFrame: Over the duration of the study (24 months in average)
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Abbeville
city: Aix-en-Provence
country: France
facility: CH Aix en Provence
city: Amiens
country: France
facility: Clinique Victor Pauchet
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: CH Annecy
city: Brest
country: France
facility: CHRU Brest
city: Cherbourg
country: France
facility: CH Cotentin
city: Compiègne
country: France
facility: CH Compiègne-Noyon
city: Compiègne
country: France
facility: CH Compiègne
city: Contamine-sur-Arve
country: France
facility: CH Alpes-Léman
city: Créteil
country: France
facility: CHI Créteil
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle - Ré-Aunis
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre (AP-HP)
city: Le Puy-en-Velay
country: France
facility: CH Le Puy-en-Velay
city: Libourne
country: France
facility: CH Libourne
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: HCL- Hôpital Croix-Rousse
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
city: Montpellier
country: France
facility: Montpellier Hospital Center
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Hôpital Cochin (AP-HP)
city: Pau
country: France
facility: CH Pau
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Roscoff
country: France
facility: Fondation Ildys
city: Rouen
country: France
facility: CHU Rouen
city: Suresnes
country: France
facility: Hôpital Foch
city: Tarbes
country: France
facility: CH Tarbes Lourdes
city: Toulouse
country: France
facility: CHU Toulouse
city: Troyes
country: France
facility: CH Troyes
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Saint-Denis
country: Réunion
facility: CHU La Réunion Félix Guyon
city: Saint-Pierre
country: Réunion
facility: CHU La Réunion Sud
Study officials:
affiliation: CHU NICE
name: Sylvie Leroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.