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RecruitingNCT06487273Home-BRACUpdated Nov 2, 2026

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

An interventional study of SIMEOX and Remote Physiotherapy in Non-cystic Fibrosis Bronchiectasis, sponsored by Physio-Assist. Recruiting at 57 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Physio-Assist · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Updated Nov 2, 2026Primary completion movedStudy completion moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
468
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

Two main objectives will be assessed sequentially:

  • 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.
  • 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.
02

Conditions studied

  • Non-cystic Fibrosis Bronchiectasis

Browse trials for

Keywords

  • Non-CF Bronchiectasis
  • Bronchial clearance
03

In context

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

This study's planned enrollment of 468 is above the median of 60 across 263 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Physio-Assist is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 2, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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:

  1. 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);

  2. 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 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 ), 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
468 participants (estimated)

Study arms

  • Other
    Control

    Remote Physiotherapy + standard of care

    Other: Remote Physiotherapy

  • Experimental
    SIMEOX

    SIMEOX device combined with Remote Physiotherapy + standard of care

    Device: SIMEOX · Other: Remote Physiotherapy

Interventions

  • DeviceSIMEOX

    Use of the CE-marked SIMEOX medical device. No specific limitation of the number of use but recommendation to use it daily (and more if needed).

  • OtherRemote Physiotherapy

    Remote Physiotherapy with physiotherapists, once a month for the first 3 months and once every 3 months after

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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)

  28. 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

  29. 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

  30. 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)

  31. 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

  32. 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

  33. 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)

  34. 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

  35. 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

  36. 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)

  37. 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

  38. 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

  39. 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)

  40. 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

  41. 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

  42. 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)

  43. 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

  44. 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

  45. 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)

  46. 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)

  47. 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)

07

Study locations

45 of 57 sites recruiting
08

References and documents

Publications

  • Hamidfar R, Murris-Espin M, Mahot M, Abouly R, Gauchez H, Jacques S, Joffray E, Arnol N, Morin L, Leroy S, Borel JC. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023 Jul;10(1):e001722. doi: 10.1136/bmjresp-2023-001722. PubMed 37524523 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added, 2 sites removed
Show 2 added (2 United Kingdom)
  • Royal Papworth Hospital, NHS Foundation Trust · Cambridge, United Kingdom
  • Royal Brompton & Harefield Hospitals, Guy's & St Thomas' NHS Foundation Trust · London, United Kingdom
Show 2 removed
  • Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust · Birmingham, United Kingdom
  • Wythenshawe Hospital, Manchester University, NHS Foundation Trust · Manchester, United Kingdom
Nov 2, 2026
Primary completion
Dec 2027→Dec 2028
Nov 2, 2026
Study completion
Dec 2027→Dec 2028
Nov 2, 2026
Enrollment
622→468
Nov 2, 2026
Eligibility
3 exclusion criteria added
What changed in the criteria
Exclusion criteria
  • AddedHowever, 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:
  • AddedFor 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);
  • AddedFor 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
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    2 sites added, 2 sites removed
    Show 2 added (2 United Kingdom)
    • Royal Papworth Hospital, NHS Foundation Trust · Cambridge, United Kingdom
    • Royal Brompton & Harefield Hospitals, Guy's & St Thomas' NHS Foundation Trust · London, United Kingdom
    Show 2 removed
    • Heartland Hospital, University Hospitals Birmingham, NHS Foundation Trust · Birmingham, United Kingdom
    • Wythenshawe Hospital, Manchester University, NHS Foundation Trust · Manchester, United Kingdom
    Primary completion Dec 2027→Dec 2028
    Study completion Dec 2027→Dec 2028
    Enrollment 622→468
    Eligibility 3 exclusion criteria added
    What changed in the criteria
    Exclusion criteria
    • AddedHowever, 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:
    • AddedFor 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);
    • AddedFor 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
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06487273
Lead sponsor
Physio-Assist
Collaborators
Icadom, Clinact
Responsible party
Sponsor
First posted
Jul 5, 2024
Start date
Feb 3, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Pauline Périnet-Marquet
Contact
p.perinet-marquet@icadom.com
+33 7 63 23 66 15
Laurent Morin
Contact
laurent.morin@inogen.net
+33 6 03 27 30 12
Sylvie Leroy, MD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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