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

Physio-Assist622 enrolled

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).

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (57)

CH Abbeville

Abbeville, France

RECRUITING

CH Aix en Provence

Aix-en-Provence, France

RECRUITING

CH Albi

Albi, France

RECRUITING

Clinique Victor Pauchet

Amiens, France

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Over the duration of the study (24 months in average)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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).

Time frame: 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.

Time frame: Over the duration of the study (24 months in average)

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

Overview

Conditions

Interventions

Eligibility

Locations (57)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts