NCT06237348Completed
Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH
Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
This pilot RCT will assess benefits of Simeox technology on lung function, respiratory symptoms, health-related quality of life, subjective efficiency, device adherence at home, Patient satisfaction, tolerance, safety, and telecare feasibility.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 11 Jan 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Physio-Assist
- Diseases
- Cystic fibrosis
- NCT number
- NCT06237348
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Dec 2023 to the primary completion date, 30 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
- Patient on lung transplant list
- Recent lung surgery
- Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator
Other illness
- Unstable severe cardiac disease or hemodynamic instability
Lab values
- Any contraindication to an instrumental bronchial clearance technique (up to the investigator)
Other
- Recent episode of severe haemoptysis
- Cystic fibrosis or COPD as dominant diagnosis
- Severe lung injuries
- Inhalation support (continuous ventilatory support)
- Tracheostomy
- Uncontrolled GERD
- Inability to perform PFT or 6MWT
- Patient not available or wishing to move to a different region within 2 months of inclusion
- Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures.
Who the study is looking for
- Patient with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD
- Overproduction of mucus (ie: estimated bronchorrhea \>10mL/day).
- Pulmonary exacerbation (in- or outpatients)
- Age \> 18 years old
- Patient able to understand the study and to perform the 2-month follow up visit
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jagiellonian University Medical College Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| N. Barlicki University Hospital No 1 Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.