Cystic Fibrosis in ChildrenNCT04084041
Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis
A study testing Simeox and CCPT in people with Cystic Fibrosis in Children and Airway Clearance Impairment, run by Physio-Assist at 1 site in Poland.
Trial summary
Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cystic Fibrosis in Children, Airway Clearance Impairment
- What is being tested?
- Simeox and CCPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 10 Sep 2019to 15 Feb 2021
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology
- willing and able to cooperate and learn new technic of drainage.
- age 8-18 years, on the date of admission to hospital.
- confirmed diagnosis of CF as determined by the investigator.
- able to perform pulmonary tests
Who cannot join
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following:
- contraindications to bronchial chest physiotherapy
- hemoptysis
- pneumothorax
- heart disease
- recent chest surgery
- recent chest injury
- history of lung transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization
Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.
- Being tested
- Simeox, CCPT
- Keywords
- Airway clearance technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimeoxDevice
Airway clearance device
CCPTOther
Conventional chest physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Device group Receives: Device: Simeox; Other: CCPT |
| Conventional chest physiotherapy | Active comparator | Control group Receives: Device: Simeox; Other: CCPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total lung resistance
Evolution of R5hz - Impulse Oscillometry (IOS) from baseline
Measured: 1 month
Secondary outcomes (14)
Change in central lung resistance
Evolution of R20hz - Impulse Oscillometry (IOS) from baseline
Measured: 1 month
Change in peripheral lung resistance
Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline
Measured: 1 month
Change in total lung reactance
Evolution of X5hz -Impulse Oscillometry (IOS) from baseline
Measured: 1 month
Change in area of reactance (AX)
Evolution of AX -Impulse Oscillometry (IOS) from baseline
Measured: 1 month
Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Evolution of CFQ-R total score (0-100) from baseline
Measured: 1 month
Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire
Evolution of respiratory score (0-100) of CFQ-R from baseline
Measured: 1 month
Change in Forced Expiratory Volume in 1 second (FEV1)
Evolution of FEV1 (spirometry) from baseline
Measured: 1 month
Change in Forced Vital Capacity (FVC)
Evolution of FVC (spirometry) from baseline
Measured: 1 month
Change in Residual Volume (RV)
Evolution of RV (body plethysmography) from baseline
Measured: 1 month
Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume
Evolution of MEF 25, 50 and 75 (spirometry) from baseline
Measured: 1 month
Change in Mean Mid Expiratory Flow (MMEF)
Evolution of MMEF (spirometry) from baseline
Measured: 1 month
Change in lung clearance index (LCI)
Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline
Measured: 1 month
Pulmonary exacerbation
Rate of pulmonary exacerbation
Measured: 1 month
Adverse events
Rate of adverse events related or not related to intervention
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start10 Sep 2019
- Primary completion31 Jan 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in ChildrenStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physio-Assist
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dorota Sands, MD, PhD, Principal investigator, IMiD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084041
- Sponsor's protocol ID
- HOMECARE_CF
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2019
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sands D, Walicka-Serzysko K, Milczewska J, Postek M, Jeneralska N, Cichocka A, Siedlecka E, Borawska-Kowalczyk U, Morin L. Efficacy of the Simeox(R) Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children (Basel). 2023 Jan 23;10(2):204. doi: 10.3390/children10020204.
PubMed 36832333
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization
- ClinicalTrials.gov ID
- NCT04084041
- Acronym / sponsor ID
- HOMECARE_CF
- Keywords
- Airway clearance technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Physio-AssistIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 10 Sep 2019 (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.
Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Simeox, Other: CCPTDevice group |
| Conventional chest physiotherapy | Active comparator | Device: Simeox, Other: CCPTControl group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology
- willing and able to cooperate and learn new technic of drainage.
- age 8-18 years, on the date of admission to hospital.
- confirmed diagnosis of CF as determined by the investigator.
- able to perform pulmonary tests
Key exclusion criteria (8 listed)
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following:
- contraindications to bronchial chest physiotherapy
- hemoptysis
- pneumothorax
- heart disease
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 |
|---|---|---|
| SimeoxAirway clearance device | Device | Conventional chest physiotherapy, Device |
| CCPTConventional chest physiotherapy | Other | Conventional chest physiotherapy, Device |
Primary outcome
Change in total lung resistance
Time frame: 1 month
Evolution of R5hz - Impulse Oscillometry (IOS) from baseline
14 secondary outcomes
Change in central lung resistance
Time frame: 1 month
Change in peripheral lung resistance
Time frame: 1 month
Change in total lung reactance
Time frame: 1 month
Change in area of reactance (AX)
Time frame: 1 month
Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: 1 month
Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire
Time frame: 1 month
Change in Forced Expiratory Volume in 1 second (FEV1)
Time frame: 1 month
Change in Forced Vital Capacity (FVC)
Time frame: 1 month
Change in Residual Volume (RV)
Time frame: 1 month
Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume
Time frame: 1 month
Change in Mean Mid Expiratory Flow (MMEF)
Time frame: 1 month
Change in lung clearance index (LCI)
Time frame: 1 month
Pulmonary exacerbation
Time frame: 1 month
Adverse events
Time frame: 1 month
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 24 Sep 2025.
- Results publication: PubMed 36832333Sands D, Walicka-Serzysko K, Milczewska J, Postek M, Jeneralska N, Cichocka A, Siedlecka E, Borawska-Kowalczyk U, Morin L. Efficacy of the Simeox(R) Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children (Basel). 2023 Jan 23;10(2):204. doi: 10.3390/children10020204.
- Individual participant dataSharing planned: No
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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.
Dorota Sands, MD, PhD principal investigator
IMiD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simeox and CCPT in people with Cystic Fibrosis in Children and Airway Clearance Impairment, run by Physio-Assist at 1 site 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 8 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in total lung resistance (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084041, which also lists 1 linked publication.
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 24 Sep 2025.