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Tests a home airway clearance device in adults with non-cystic fibrosis bronchiectasis

Tests the SIMEOX device at home, with remote physiotherapy, in adults with bronchiectasis.

Key facts

Who runs it
Physio-Assist
Where
Abbeville, Aix-en-Provence, Albi, Amiens, Angers, Annecy, Aressy, Brest, Cherbourg, Compiègne, Contamine-sur-Arve, Créteil, Dieulefit, Grenoble, Hyères, La Rochelle, Le Kremlin-Bicêtre, Le Puy-en-Velay, Libourne, Limoges, Lyon, Marseille, Montivilliers, Montpellier, Nice, Nîmes, Paris, Pau, Perpignan, Poitiers, Reims, Rennes, Roscoff, Rouen, Saint-Quentin, Suresnes, Tarbes, Toulouse, Troyes, and Vannes, FranceSee the 41 sitesAlso in 5 other countries, 16 sites
Trial code
Registry title
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Status
Recruiting
People taking part
468 people, planned
Started
3 Feb 2025
Expected to end
Dec 2028
Type of study
Interventional, 2 groups
Treatments tested
  • SIMEOX
  • Remote Physiotherapy
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-cystic fibrosis bronchiectasis who produce sputum regularly and have had recent flare-ups. It tests the SIMEOX airway clearance device used at home with remote physiotherapy.

Age
Over 18 years
Sex
Men and women
Disease stage
Bronchiectasis not caused by cystic fibrosis, confirmed by a CT scan. Clinically stable: at least 4 weeks since the last exacerbation and no change in disease-modifying treatment for 4 weeks.
Earlier treatment
At least 2 pulmonary exacerbations in the past 12 months that needed a change in treatment, or at least 1 that needed hospital admission. People already using SIMEOX, a chest vest (HFCWO) or IPV at home cannot join.

Main reasons for not taking part

  • Cystic fibrosis
  • Active smoking
  • Mainly COPD or asthma without qualifying bronchiectasis
  • Unstable heart problems
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Predominant diagnosis of Chronic obstructive pulmonary disease (COPD) or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis; However, patients with COPD or asthma and concomitant bronchiectasis may be eligible if they present symptoms of bronchiectasis (e. g. persistent cough, excessive mucus production, fatigue, shortness of breath, chest pain, etc.) and meet the following conditions:
  • For patients with asthma: documented evidence of bronchiectasis exacerbations (e.g., increased sputum production, sputum purulence, or infective exacerbation) requiring treatment with antibiotics, rather than exacerbation predominantly caused by bronchospasm or loss of asthma control; 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
  • 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
  • For patients with COPD: bronchiectasis affecting at one or more pulmonary segment in at least two pulmonary lobes, as defined by the EMBARK group COPD-bronchiectasis association criteria (ROSE criteria)

Where in France

Also in 5 other countries, 16 sites

  • CH AbbevilleAbbeville, FranceContact: Pauline Périnet-MarquetTaking people
  • CH Aix-en-ProvenceAix-en-Provence, FranceContact: Pauline Périnet-MarquetTaking people
  • CH ALBIAlbi, FranceContact: Pauline Périnet-MarquetTaking people
  • Chu Amiens PicardieAmiens, FranceContact: Pauline Périnet-MarquetTaking people
  • Clinique Victor PauchetAmiens, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU AngersAngers, FranceContact: Pauline Périnet-MarquetTaking people
  • CH AnnecyAnnecy, FranceContact: Pauline Périnet-MarquetTaking people
  • Clinique AressyAressy, FranceContact: Pauline Périnet-MarquetTaking people
  • CHRU BrestBrest, FranceContact: Pauline Périnet-MarquetTaking people
  • CH CotentinCherbourg, FranceContact: Pauline Périnet-MarquetTaking people
  • CH Compiègne NoyonCompiègne, FranceContact: Pauline Périnet-MarquetTaking people
  • CH Alpes-LémanContamine-sur-Arve, FranceContact: Pauline Périnet-MarquetTaking people
  • Chi CreteilCréteil, FranceContact: Pauline Périnet-MarquetTaking people
  • CFR DieulefitDieulefit, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU Grenoble AlpesGrenoble, FranceContact: Pauline Périnet-MarquetTaking people
  • HCL - centre de HyèresHyères, FranceContact: Pauline Périnet-MarquetTaking people
  • Groupe Hospitalier La Rochelle-Ré-AunisLa Rochelle, FranceContact: Pauline Périnet-MarquetNo longer taking part
  • Hôpital Bicêtre AP-HPLe Kremlin-Bicêtre, FranceContact: Pauline Périnet-MarquetNo longer taking part
  • CH Le Puy en VelayLe Puy-en-Velay, FranceContact: Pauline Périnet-MarquetTaking people
  • CH LibourneLibourne, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU LimogesLimoges, FranceContact: Pauline Périnet-MarquetTaking people
  • HCL - Hôpital Croix RousseLyon, FranceContact: Pauline Périnet-MarquetTaking people
  • Hôpital Européen de MarseilleMarseille, FranceContact: Pauline Périnet-MarquetTaking people
  • Groupe Hospitalier Du HavreMontivilliers, FranceContact: Pauline Périnet-MarquetNo longer taking part
  • Montpellier Hospital CenterMontpellier, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU NiceNice, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU NîmesNîmes, FranceContact: Pauline Périnet-MarquetTaking people
  • Hôpital Cochin AP-HPParis, FranceContact: Pauline Périnet-MarquetTaking people
  • CH PauPau, FranceContact: Pauline Périnet-MarquetTaking people
  • Ch PerpignanPerpignan, FranceContact: Pauline Périnet-MarquetNot yet recruiting
  • CHU PoitiersPoitiers, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU ReimsReims, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU RennesRennes, FranceContact: Pauline Périnet-MarquetTaking people
  • Fondation ILDYSRoscoff, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU RouenRouen, FranceContact: Pauline Périnet-MarquetNo longer taking part
  • CH St QuentinSaint-Quentin, FranceContact: Pauline Périnet-MarquetTaking people
  • Hopital FochSuresnes, FranceContact: Pauline Périnet-MarquetTaking people
  • CH Tarbes-LourdesTarbes, FranceContact: Pauline Périnet-MarquetTaking people
  • CHU ToulouseToulouse, FranceContact: Pauline Périnet-MarquetTaking people
  • Ch TroyesTroyes, FranceContact: Pauline Périnet-MarquetTaking people
  • CH Bretagne AtlantiqueVannes, FranceContact: Pauline Périnet-MarquetTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • ControlOther group

    Remote Physiotherapy + standard of care

    Treatment: Remote Physiotherapy

  • SIMEOXTreatment being tested

    SIMEOX device combined with Remote Physiotherapy + standard of care

    Treatment: SIMEOX and Remote Physiotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests a home airway clearance device in adults with non-cystic fibrosis bronchiectasisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 November 2026