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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (5 UK sites)
Royal Victoria Hospital, Belfast Health and Social Care Trust
Belfast BT12 6BA, United Kingdom
Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust
Birmingham B9 5SS, United Kingdom
NHS Lothian
Edinburgh EH3 9DN, United Kingdom
Wythenshawe Hospital, Manchester University, NHS Foundation Trust
Manchester M23 9LT, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
Pauline Périnet-Marquet
Sponsor contactCONTACT
Laurent Morin
Sponsor contactCONTACT
