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New home device aims to ease breathing and cut infections in lung disease

NCT ID NCT06487273

Disease control Sponsor: Physio-Assist Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests whether a device called SIMEOX, used at home with remote physiotherapy, can improve quality of life and reduce lung infections in people with bronchiectasis (a chronic lung disease with mucus buildup). About 622 adults will use the device daily or get standard care. The goal is to see if this approach helps clear mucus better and lowers the number of serious flare-ups over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SIMEOX airway clearance device and remote physiotherapy
What this could lead to
If it works, this could offer a convenient home-based treatment to improve daily life and reduce serious lung infections for people with bronchiectasis.
What could go wrong
This is a mid-stage trial with 622 participants, so results are not yet proven. The device may not work for everyone, and daily use could be burdensome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 622 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-cystic fibrosis bronchiectasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    54 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CFR Dieulefit

    RECRUITING

    Dieulefit, France

  • CH Abbeville

    RECRUITING

    Abbeville, France

  • CH Aix en Provence

    RECRUITING

    Aix-en-Provence, France

  • CH Albi

    RECRUITING

    Albi, France

  • CH Alpes-Léman

    RECRUITING

    Contamine-sur-Arve, 74130, France

  • CH Annecy

    RECRUITING

    Annecy, France

  • CH Bretagne Atlantique

    RECRUITING

    Vannes, France

  • CH Compiègne-Noyon

    RECRUITING

    Compiègne, 60200, France

  • CH Cotentin

    RECRUITING

    Cherbourg, France

  • CH Le Puy-en-Velay

    RECRUITING

    Le Puy-en-Velay, 43000, France

  • CH Libourne

    RECRUITING

    Libourne, 33500, France

  • CH Pau

    RECRUITING

    Pau, 64000, France

  • CH Perpignan

    NOT_YET_RECRUITING

    Perpignan, France

  • CH St Quentin

    RECRUITING

    Saint-Quentin, France

  • CH Tarbes Lourdes

    RECRUITING

    Tarbes, France

  • CH Troyes

    RECRUITING

    Troyes, France

  • CHI Créteil

    RECRUITING

    Créteil, 94000, France

  • CHRU Brest

    RECRUITING

    Brest, 29200, France

  • CHU Amiens Picardie

    RECRUITING

    Amiens, France

  • CHU Angers

    RECRUITING

    Angers, 49033, France

  • CHU Grenoble-Alpes

    RECRUITING

    Grenoble, 38043, France

  • CHU La Réunion Félix Guyon

    RECRUITING

    Saint-Denis, Reunion

  • CHU La Réunion Sud

    RECRUITING

    Saint-Pierre, Reunion

  • CHU Limoges

    RECRUITING

    Limoges, France

  • CHU Nice

    RECRUITING

    Nice, 06002, France

  • CHU Nîmes

    RECRUITING

    Nîmes, 30900, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU Reims

    RECRUITING

    Reims, 51092, France

  • CHU Rennes

    RECRUITING

    Rennes, 35033, France

  • CHU Rouen

    WITHDRAWN

    Rouen, France

  • CHU Toulouse

    RECRUITING

    Toulouse, France

  • Centro Clínico Académico de Braga (2CA-Braga) ULS de Braga

    NOT_YET_RECRUITING

    Braga, 4710-243, Portugal

  • Clinique Aressy

    RECRUITING

    Aressy, 64320, France

  • Clinique Victor Pauchet

    RECRUITING

    Amiens, 80090, France

  • Fondation Ildys

    RECRUITING

    Roscoff, 29684, France

  • Groupe Hospitalier La Rochelle - Ré-Aunis

    SUSPENDED

    La Rochelle, France

  • Groupe Hospitalier du Havre

    WITHDRAWN

    Montivilliers, France

  • HCL - centre de Hyères

    RECRUITING

    Hyères, France

  • HCL- Hôpital Croix-Rousse

    RECRUITING

    Lyon, 69004, France

  • Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust

    NOT_YET_RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Hospital Senhora de Oliveira Guimarães ULS Alto Ave

    NOT_YET_RECRUITING

    Creixomil, 4835-044, Portugal

  • Hôpital Bicêtre (AP-HP)

    WITHDRAWN

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Cochin (AP-HP)

    RECRUITING

    Paris, 75014, France

  • Hôpital Européen de Marseille

    RECRUITING

    Marseille, France

  • Hôpital Foch

    RECRUITING

    Suresnes, France

  • Instituto CUF

    NOT_YET_RECRUITING

    Porto, 4460-188, Portugal

  • LMU Klinikum

    RECRUITING

    München, 80336, Germany

  • Medizinische Klinik V University hospital

    RECRUITING

    Aachen, 52074, Germany

  • Montpellier Hospital Center

    RECRUITING

    Montpellier, 34090, France

  • NHS Lothian

    RECRUITING

    Edinburgh, EH3 9DN, United Kingdom

  • Royal Victoria Hospital, Belfast Health and Social Care Trust

    RECRUITING

    Belfast, BT12 6BA, United Kingdom

  • Szpital Uniwersytecki w Krakowie

    NOT_YET_RECRUITING

    Krakow, 30-688, Poland

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Universitätsklinikum Schleswig-Holstein

    NOT_YET_RECRUITING

    Lübeck, 23538, Germany

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    NOT_YET_RECRUITING

    Poznan, 60-355, Poland

  • Uniwersytet Medyczny w Łodzi Nr 1 im. Norberta Barlickiego

    RECRUITING

    Lodz, 90-153, Poland

  • Wythenshawe Hospital, Manchester University, NHS Foundation Trust

    NOT_YET_RECRUITING

    Manchester, M23 9LT, United Kingdom

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