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

Sponsor: Physio-Assist

NCT ID: NCT06487273

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
SIMEOX (device), Remote Physiotherapy (other)
How long the study runs
Study runs about 34 months (dates as stated)
About the drug or intervention
SIMEOX — device: Use of the CE-marked SIMEOX medical device. · Remote Physiotherapy — other: Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at long-term use of the SIMEOX device at home by people with non-cystic fibrosis bronchiectasis, a long-term lung condition where the airways are widened and produce too much mucus. The trial is sponsored by Physio-Assist, the company that makes the device. It aims to see how the device works when used at home over time.

Who can take part

  • Adults aged over 18, male or female
  • Main diagnosis of bronchiectasis that is not caused by cystic fibrosis, confirmed by a CT scan
  • Regular and long-term production of sputum (phlegm)
  • Clinically stable when joining: at least 4 weeks since the last flare-up, with no change in treatment for 4 weeks
  • At least two flare-ups needing treatment changes in the past 12 months, or at least one flare-up needing a hospital stay
  • Able, in the researcher's view, to use the device and follow the study steps, both physically and mentally
  • Covered by a social security scheme, where this applies in the country

Who may not be able to

  • Already using at home a powered mucus-clearing device such as SIMEOX, a high-frequency chest wall oscillation device (a vibrating vest), or intrapulmonary percussion ventilation
  • Using a powered cough-assist machine at home for less than a year
  • Cystic fibrosis
  • Main diagnosis of COPD (chronic obstructive pulmonary disease), asthma, or bronchiectasis caused by a specific blockage, sarcoidosis, or active allergic bronchopulmonary aspergillosis
  • Current smoking
  • Suspected or unstable immune system problems, or a risk of stopping long-term immune-suppressing medicine during the study
  • Unstable heart conditions, unstable blood pressure, or uncontrolled acid reflux
  • Recent collapsed lung (pneumothorax) or higher risk of one
  • Unable to cough strongly and independently
  • Significant coughing up of blood in the 6 weeks before joining
  • Use of a breathing tube in the neck or windpipe, or daytime mask ventilation for more than 16 hours
  • Neuromuscular disease with weak breathing muscles, or trouble clearing secretions from the throat and mouth
  • Risk of breathing in food or liquid into the lungs
  • Breathing muscle weakness that means extra breathing effort cannot be tolerated
  • Severe restrictive lung disease (total lung capacity below 60%) or bullous emphysema
  • Heart, lung, or gullet surgery in the last 3 months, or serious sudden lung injury in the last 3 months
  • Taking part in another treatment study in the past month or during this study
  • Unable to take part fully, for example planning to move away before the study ends
  • Pregnant or breastfeeding women, women planning pregnancy, or those who cannot use contraception and test pregnant
  • People deprived of liberty by a court or under legal protection

What taking part involves

  • • Using the SIMEOX device at home — a device designed to help clear mucus from the lungs
  • • The exact schedule of device use and study procedures is not stated — ask the trial team

Time commitment: Length of the study and number of visits are not stated — ask the trial team; taking part involves using the SIMEOX device at home.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
622
Started
2025-02-03
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for non-cystic fibrosis bronchiectasis
  • • NA - 622 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-cystic fibrosis bronchiectasis

Where?

  • • Belfast - Royal Victoria Hospital, Belfast Health and Social Care Trust
  • • Birmingham - Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust
  • • Edinburgh - NHS Lothian
  • • Manchester - Wythenshawe Hospital, Manchester University, NHS Foundation Trust
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Non-cystic Fibrosis Bronchiectasis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a change in specific treatment for these exacerbations

What the study is looking for

  • ✓Male or female aged over 18 years
  • ✓Predominant diagnosis of Non CF bronchiectasis disease, excluding cystic fibrosis, confirmed by computed tomography...
  • ✓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...

Who cannot take part

  • ✗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:
See the full 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

Where Is This Study? (5 UK sites)

Royal Victoria Hospital, Belfast Health and Social Care Trust

Belfast BT12 6BA, United Kingdom

Recruiting
Site contact (verified)

Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust

Birmingham B9 5SS, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

NHS Lothian

Edinburgh EH3 9DN, United Kingdom

Recruiting
Site contact (verified)

Wythenshawe Hospital, Manchester University, NHS Foundation Trust

Manchester M23 9LT, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Pauline Périnet-Marquet

Sponsor contact

CONTACT

+33 7 63 23 66 15 p.perinet-marquet@icadom.com

Laurent Morin

Sponsor contact

CONTACT

+33 6 03 27 30 12 laurent.morin@inogen.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-07