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

Overview

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.

Interventions

• 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).
• Other Remote Physiotherapy
  Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after

Primary outcome measures

• Quality of life SGRQ at 6 months [Time frame: Change from baseline at 6 months]
• The annual rate of pulmonary exacerbations [Time frame: Over the duration of the study (24 months in average)]

Secondary outcome measures (12)

• 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]

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 (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 41 centers

• CH Abbeville — Abbeville
• CH Aix en Provence — Aix-en-Provence
• CH Albi — Albi
• Clinique Victor Pauchet — Amiens
• CHU Amiens Picardie — Amiens
• CHU Angers — Angers
• CH Annecy — Annecy
• Clinique Aressy — Aressy
• … and 33 more centers

United Kingdom · 5 centers

• Royal Victoria Hospital, Belfast Health and Social Care Trust — Belfast
• Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust — Birmingham
• NHS Lothian — Edinburgh
• Wythenshawe Hospital, Manchester University, NHS Foundation Trust — Manchester
• The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne

Germany · 3 centers

• Medizinische Klinik V University hospital — Aachen
• Universitätsklinikum Schleswig-Holstein — Lübeck
• LMU Klinikum — München

Poland · 3 centers

• Szpital Uniwersytecki w Krakowie — Krakow
• Uniwersytet Medyczny w Łodzi Nr 1 im. Norberta Barlickiego — Lodz
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan

Portugal · 3 centers

• Centro Clínico Académico de Braga (2CA-Braga) ULS de Braga — Braga
• Hospital Senhora de Oliveira Guimarães ULS Alto Ave — Creixomil
• Instituto CUF — Porto

Reunion · 2 centers

• CHU La Réunion Félix Guyon — Saint-Denis
• CHU La Réunion Sud — Saint-Pierre

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. PMID 37524523

Identifiers

NCT: NCT06487273 · 2023-A01095-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗