Status:
RECRUITING
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Lead Sponsor:
Physio-Assist
Collaborating Sponsors:
Icadom
Clinact
Conditions:
Non-cystic Fibrosis Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 alt...
Detailed Description
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 rela...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT06487273
Start Date
February 1 2025
End Date
December 1 2027
Last Update
August 26 2025
Active Locations (42)
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1
CH Abbeville
Abbeville, France
2
CH Aix en Provence
Aix-en-Provence, France
3
CH Albi
Albi, France
4
Clinique Victor Pauchet
Amiens, France, 80090