Non-cystic Fibrosis BronchiectasisNCT06237348
Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH
A study testing Simeox in people with Non-cystic Fibrosis Bronchiectasis and Chronic Mucus Hypersecretion, run by Physio-Assist at 2 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis, Chronic Mucus Hypersecretion
- What is being tested?
- Simeox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Dec 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
- Recent episode of severe haemoptysis
- Unstable severe cardiac disease or hemodynamic instability
- Cystic fibrosis or COPD as dominant diagnosis
- Patient on lung transplant list
- Severe lung injuries
Show all 15Show fewer
- Recent lung surgery
- Inhalation support (continuous ventilatory support)
- Tracheostomy
- Uncontrolled GERD
- Any contraindication to an instrumental bronchial clearance technique (up to the investigator)
- 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.
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Jagiellonian University Medical College
Krakow, 30-688
N. Barlicki University Hospital No 1
Lodz, 90-153
About this study
Official title: Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study
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.
Read the detailed description
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic respiratory disease with multiple etiologies characterized by an irreversible dilatation of bronchi and an impair mucociliary clearance. These alterations cause sticky mucus retention and leads to recurrent infections and chronic bronchial inflammations. Chest physiotherapy is one of the cornerstones of the management of NCFB patients, particularly to facilitate airway clearance. In NCFB patients with chronic mucus hypersecretion (CMH), it is recommended that airway clearance sessions be carried out daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy for patients can be limited due to several causes: geographical, time or healthcare professional availability constraints. In addition, few healthcare professionals are trained for bronchial drainage especially with airway clearance devices.
SIMEOX® (Physio-Assist, France) is an innovative medical device (CE medical mark) for mucus clearance. The device is connected to patient mouth with an expiratory kit circuit. When the patient starts up the device during exhalation only, SIMEOX® disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration. After device training with respiratory physiotherapist, patients can be treated at hospital and use SIMEOX® in autonomy at home. Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals.
The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX® in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation (in- or outpatients) in comparison to standard of care.
- Being tested
- Simeox, Control
- Keywords
- NCFB, CMH, Simeox, Airway clearance, ACT, Bronchiectasis, Telecare
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimeoxDevice
Daily airway clearance therapy at home during 2 months
ControlCombination product
Also called Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)
Daily airway clearance therapy at home during 2 months
| Study group | Role | What they receive |
|---|---|---|
| Simeox | Experimental | Airway clearance device Receives: Device: Simeox; Combination Product: Control |
| Control | Active comparator | Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP) Receives: Combination Product: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up
The evolution of device adherence will be described by % of self-reported sessions (0-1; 2-3; 4-7/week) by the patient over the 2-month FU (1 week, 2 weeks, 1 month and 2 months)
Measured: 2 months
Secondary outcomes (21)
To describe Simeox therapy settings (program selection) during follow-up
Simeox settings will be described by program selection (1, 2 or 3)
Measured: 2 months
To describe Simeox therapy settings (intensity) during follow-up
Simeox settings will be described by intensity (25%, 50%, 75% or 100%)
Measured: 2 months
To describe Simeox therapy settings (number of session) during follow-up
Simeox settings will be described by the number of sessions per day
Measured: 2 months
To describe Simeox therapy settings (session duration) during follow-up
Simeox settings will be described by the session duration in minutes
Measured: 2 months
To evaluate mucus quality with Simeox therapy during follow-up
Mucus quality will be evaluated during follow-up with a score from 1 to 4 (abondant - Scanty)
Measured: 2 months
To evaluate breathing quality with Simeox therapy during follow-up
Breathing quality level will be evaluated during follow-up with a score from 1 to 4 (very good - very poor)
Measured: 2 months
To evaluate ease handling of the Simeox device during follow-up
Ease of handling level will be evaluated during follow-up with a score 1 to 4 (very easy - not easy at all)
Measured: 2 months
To evaluate pain during Simeox therapy
Pain level will be evaluated during follow-up with a scale from 0 to10 (no painful - very painful)
Measured: 2 months
To evaluate fatigue during Simeox therapy
Fatigue level will be evaluated during follow-up with a scale from 0 to 10 (no fatigue - very tired)
Measured: 2 months
To evaluate ease of use of Simeox device after 2 months of therapy
Ease of use level will be evaluated at 2 month with a score from 1 to 4 (very easy - not easy at all)
Measured: 2 months
To evaluate patient preference between Simeox device and usual care after 2 months of therapy
Patient preference will be evaluated at 2 month in comparaison to conventional techniques used (yes/no)
Measured: 2 months
To evaluate patient recommendation to others patients of Simeox device after 2 months of therapy
Patient recommendation to others patients will be evaluated at 2 month (yes/no)
Measured: 2 months
Evaluate the feasibility of telecare during follow-up
Feasibility of telecare during follow-up will be estimated by the percent of call visit performed with the patients compared to the number of call visits scheduled in the protocol
Measured: 2 months
To evaluate the effect of Simeox on respiratory symptoms in NCFB patients after 2 months of therapy
The change in respiratory symptoms score from baseline (hospital discharge) to 2-month FU will be measured with the Chronic Airways Assessment Test (CAT) questionaire
Measured: 2 months
To evaluate the effect of Simeox on the health-related quality of life of NCFB patients after 2 months of therapy
The change in quality of life from baseline (hospital discharge) to 2-month FU will be measured with the St Georges Respiratory Questionnaire (SGRQ)
Measured: 2 months
To evaluate the effect of Simeox on Forced Expiratory Volume at 1 seconde (FEV1) after 2 monts of therapy
The change in FEV1 from baseline (hospital discharge) to 2-month FU will be measured with spirometry
Measured: 2 months
To evaluate the effect of Simeox on Forced Vital Capacity (FVC) after 2 monts of therapy
The change in FVC from baseline (hospital discharge) to 2-month FU will be measured with spirometry
Measured: 2 months
To evaluate the effect of Simeox on Forced Expiratory Flow (FEF) at 25%, 50% and 75% of FVC after 2 monts of therapy
The change in FEF at 25%, 50% and 75% from baseline (hospital discharge) to 2-month FU will be measured with spirometry
Measured: 2 months
To evaluate the effect of Simeox on dyspnea after 2 monts of therapy
The change in dyspnea from baseline (hospital discharge) to 2-month FU will be measured with the modified Medical Research Council (mMRC) questionnaire
Measured: 2 months
To evaluate the effect of Simeox on exercise capacity after 2 monts of therapy
The change in walking distance from baseline (hospital discharge) to 2-month FU will be measured with the 6-min walking test (6MWT)
Measured: 2 months
To evaluate safety of Simeox
The safety of Simeox will be assessed by the rate and severity of Side effects during follow-up
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Dec 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open-label, parallel, Multicenter Randomized controlled trial,
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physio-Assist
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lodz, University Hospital in Krakow
- Responsible party
- Sponsor
- Investigators
- Wojciech PIOTROWSKI, MD, PhD, Study director, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237348
- Sponsor's protocol ID
- Simeox 1.1 290623
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study
- ClinicalTrials.gov ID
- NCT06237348
- Acronym / sponsor ID
- Simeox 1.1 290623
- Keywords
- NCFB, CMH, Simeox, Airway clearance, ACT, Bronchiectasis, Telecare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Physio-AssistIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Lodz, University Hospital in Krakow
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic respiratory disease with multiple etiologies characterized by an irreversible dilatation of bronchi and an impair mucociliary clearance. These alterations cause sticky mucus retention and leads to recurrent infections and chronic bronchial inflammations. Chest physiotherapy is one of the cornerstones of the management of NCFB patients, particularly to facilitate airway clearance. In NCFB patients with chronic mucus hypersecretion (CMH), it is recommended that airway clearance sessions be carried out daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy for patients can be limited due to several causes: geographical, time or healthcare professional availability constraints. In addition, few healthcare professionals are trained for bronchial drainage especially with airway clearance devices.
SIMEOX® (Physio-Assist, France) is an innovative medical device (CE medical mark) for mucus clearance. The device is connected to patient mouth with an expiratory kit circuit. When the patient starts up the device during exhalation only, SIMEOX® disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration. After device training with respiratory physiotherapist, patients can be treated at hospital and use SIMEOX® in autonomy at home. Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals.
The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX® in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation (in- or outpatients) in comparison to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, parallel, Multicenter Randomized controlled trial,
| Arm | Type | Receives |
|---|---|---|
| Simeox | Experimental | Device: Simeox, Combination Product: ControlAirway clearance device |
| Control | Active comparator | Combination Product: ControlUsual chest physiotherapy (manual, breathing exercise, PEP/oPEP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
- Recent episode of severe haemoptysis
- Unstable severe cardiac disease or hemodynamic instability
- Cystic fibrosis or COPD as dominant diagnosis
- Patient on lung transplant list
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimeoxDaily airway clearance therapy at home during 2 months | Device | Simeox |
| ControlAlso: Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)Daily airway clearance therapy at home during 2 months | Combination product | Control, Simeox |
Primary outcome
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up
Time frame: 2 months
The evolution of device adherence will be described by % of self-reported sessions (0-1; 2-3; 4-7/week) by the patient over the 2-month FU (1 week, 2 weeks, 1 month and 2 months)
21 secondary outcomes
To describe Simeox therapy settings (program selection) during follow-up
Time frame: 2 months
To describe Simeox therapy settings (intensity) during follow-up
Time frame: 2 months
To describe Simeox therapy settings (number of session) during follow-up
Time frame: 2 months
To describe Simeox therapy settings (session duration) during follow-up
Time frame: 2 months
To evaluate mucus quality with Simeox therapy during follow-up
Time frame: 2 months
To evaluate breathing quality with Simeox therapy during follow-up
Time frame: 2 months
To evaluate ease handling of the Simeox device during follow-up
Time frame: 2 months
To evaluate pain during Simeox therapy
Time frame: 2 months
To evaluate fatigue during Simeox therapy
Time frame: 2 months
To evaluate ease of use of Simeox device after 2 months of therapy
Time frame: 2 months
To evaluate patient preference between Simeox device and usual care after 2 months of therapy
Time frame: 2 months
To evaluate patient recommendation to others patients of Simeox device after 2 months of therapy
Time frame: 2 months
Evaluate the feasibility of telecare during follow-up
Time frame: 2 months
To evaluate the effect of Simeox on respiratory symptoms in NCFB patients after 2 months of therapy
Time frame: 2 months
To evaluate the effect of Simeox on the health-related quality of life of NCFB patients after 2 months of therapy
Time frame: 2 months
To evaluate the effect of Simeox on Forced Expiratory Volume at 1 seconde (FEV1) after 2 monts of therapy
Time frame: 2 months
To evaluate the effect of Simeox on Forced Vital Capacity (FVC) after 2 monts of therapy
Time frame: 2 months
To evaluate the effect of Simeox on Forced Expiratory Flow (FEF) at 25%, 50% and 75% of FVC after 2 monts of therapy
Time frame: 2 months
To evaluate the effect of Simeox on dyspnea after 2 monts of therapy
Time frame: 2 months
To evaluate the effect of Simeox on exercise capacity after 2 monts of therapy
Time frame: 2 months
To evaluate safety of Simeox
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech PIOTROWSKI, MD, PhD study director
Medical University of Lodz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simeox in people with Non-cystic Fibrosis Bronchiectasis and Chronic Mucus Hypersecretion, run by Physio-Assist at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.