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Evaluation of the SIMEOX Device for Bronchiectasis Management at Home

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

Not applicable Interventional Physio-Assist · NCT06487273

This study is testing if using the SIMEOX device along with remote physiotherapy can help people with bronchiectasis feel better and have fewer breathing problems compared to standard care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment622 (estimated)
Ages18 Years and up
SexAll
SponsorPhysio-Assist Industry-sponsored
Locations57 sites (Abbeville and 56 other locations)
Trial IDNCT06487273 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the SIMEOX device, combined with remote physiotherapy, in managing non-cystic fibrosis bronchiectasis. It aims to compare the quality of life and the rate of respiratory exacerbations in patients using SIMEOX against those receiving standard care with remote physiotherapy. The study focuses on patients with chronic sputum production and a history of pulmonary exacerbations, assessing their clinical stability and ability to use the device. The goal is to provide a more accessible and effective treatment option for bronchiectasis patients who face challenges in receiving traditional physiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of non-cystic fibrosis bronchiectasis, experiencing regular sputum production and a history of pulmonary exacerbations.

Not a fit: Patients with cystic fibrosis or those who are not clinically stable may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life and reduce respiratory exacerbations for patients with non-cystic fibrosis bronchiectasis.

How similar studies have performed: While the use of devices for bronchial drainage is established, the specific application of SIMEOX in this context is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion 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 (Forced Vital Capacity \< 60% or 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 this trial is running

Abbeville and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-cystic Fibrosis BronchiectasisNon-CF BronchiectasisBronchial clearance
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.