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Pulmonary Cystic FibrosisHomeCareSIMEOXNCT04096664

Home Airway Clearance in CF Patients

A study testing SIMEOX in people with Pulmonary Cystic Fibrosis, run by Physio-Assist at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Pulmonary Cystic Fibrosis
What is being tested?
SIMEOX
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
20 sitesFrance
Study dates
10 Mar 2020to 31 Mar 2025
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient diagnosed with Cystic fibrosis
  • Stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment.
  • Age >12
  • Requiring at least 1 bronchial clearing session each week (regardless of the technique)
  • Patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol.

Who cannot join

  • Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day.
  • Patient placed on a transplant waiting list
  • Any contraindication to an instrumental bronchial clearance technique
  • Patients already own and use SIMEOX at home
  • Unavailable patient or patient wishing to move to a different region within three months after inclusion.
  • Patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment.
  • Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age < 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure.
  • Initiation of treatment with a CFTR modulator within the last 3 months

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • CHU Angers

    Angers, 49993

  • CHI Créteil

    Créteil, 94000

  • Grenoble University Hospital : pneumo-pediatric department

    Grenoble, 38043

  • Grenoble University-Affiliated Hospital : Pneumology department

    Grenoble, 38043

  • CHU Lyon HCL

    Lyon, 69495

  • Marseille University Hospital - Pneumology department

    Marseille, 13005

  • Montpellier Hospital Center

    Montpellier, 34000

  • Nice University-Affiliated Hospital : Pneumology department

    Nice, 06002

  • Nice University-Affiliated Hospital : Pneumo-pediatric department

    Nice, 06200

  • Hôpital Armand-Trousseau

    Paris, 75012

  • Hôpital Robert Debré

    Paris, 75019

  • CHU Reims

    Reims, 51092

  • Fondation Ildys

    Roscoff, 29684

  • CHU Felix Guyon

    Saint-Denis, 97400

  • CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant

    Saint-Pierre, 97448

  • CHU De la Réunion Site SUD

    Saint-Pierre, 97448

  • CHU Toulouse - Hôpital Larrey

    Toulouse, 31059

  • CHU Toulouse pediatric

    Toulouse, 31059

  • Groupement Hospitalier Brocéliande Atlantique

    Vannes, 56017

Other trials in France

About this study

Official title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.

By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves.

The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

Being tested
SIMEOX
Keywords
bronchial clearance, cystic fibrosis
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIMEOXDevice

    Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX

Study groups in NCT04096664
Study groupRoleWhat they receive
SIMEOXExperimentalUse the device for 3 months in addition to usual care
Receives: Device: SIMEOX
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory score of CFQ-R questionnaire

    Relative variation in respiratory score of the CFQ-R questionnaire (Cystic Fibrosis Questionnaire -revised version) in the SIMEOX® treated group versus control group. Score range from 0 to 100, with higher score indicating better health.

    Measured: Change from baseline at 3 months

  2. Variation of forced expiratory volume in 1 second (FEV1)

    Relative variation of the forced expiratory volume in 1 second (FEV1) in the SIMEOX® treated group versus control group

    Measured: Change from baseline at 3 months

Secondary outcomes (23)

  1. Total score of CFQ-R questionnaire

    Relative variation in the total score of the CFQ-R questionnaire (Cystic Fibrosis Questionnaire -revised version) in the SIMEOX® treated group versus control group.Score range from 0 to 100, with higher score indicating better health.

    Measured: Change from baseline at 3 months

  2. Safety of use assessed by incidence of Treatment-Emergent Adverse Events

    Take note and count all Treatment-Emergent Adverse Events to assess the safe use of SIMEOX® device autonomously at home

    Measured: During 3 months of use

  3. Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire

    Total score into a value ranging from the worst satisfaction 0 to the best satisfaction 100 of the TSQM questionnaire in the SIMEOX® treated group to assess the satisfaction

    Measured: After 3 months of use

  4. Acceptability assessed by the number of uses of SIMEOX® device

    Count the self-declared number of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the acceptability of the device.

    Measured: During 3 months of use

  5. Pulmonary forced vital capacity (FVC)

    Relative variation of forced vital capacity in liter in the SIMEOX® treated group versus control group.

    Measured: Change from baseline at 3 months

  6. FEV1/ FVC ratio

    Relative variation of FEV1/ FVC ratio in % in the SIMEOX® treated group versus control group.

    Measured: Change from baseline at 3 months

  7. Forced expiratory flow

    Relative variation of forced expiratory flow in liter per second in the SIMEOX® treated group versus control group

    Measured: Change from baseline at 3 months

  8. Static lung compliance in Liter

    Relative variation of Static lung compliance in liter in the SIMEOX® treated group versus control group

    Measured: Change from baseline at 3 months

  9. Static lung compliance in % of predicted value

    Relative variation of Static lung compliance in % of predicted value in the SIMEOX® treated group versus control group

    Measured: Change from baseline at 3 months

  10. Airway resistance

    Relative variation of Airway resistance in cmH2O per liter per second in the SIMEOX® treated group versus control group

    Measured: Change from baseline at 3 months

  11. Diffusion capacity for carbon monoxide

    Relative variation of Diffusion capacity for carbon monoxide in % in the SIMEOX® treated group versus control group

    Measured: Change from baseline at 3 months

  12. Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status

    Relative variation of the scores of EQ-5D (a standardized instrument for measuring generic health status) questionnaire in the SIMEOX® treated group versus control group to asess the generic quality of life.Each 5 descriptive items have a value ranging from 1(best) to 5 (worst) and the visual analogic scale item should be scored from 0 (worst health) to 100 (best health).

    Measured: Change from baseline at 3 months

  13. Physical activity assessed by step counts and moderate-to-vigorous physical activity

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on step counts and moderate-to-vigorous physical activity measured by actigraph device

    Measured: Change from baseline at 3 months

  14. Sleep quality assessed by sleep efficiency and fragmentation

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on sleep efficiency and fragmentation measured by actigraph device

    Measured: Change from baseline at 3 months

  15. Fatigue assessed by VAS (visual analogue scale)

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on fatigue experienced after a drainage session assessed by the VAS score between 0 and 10

    Measured: During 3 months of use

  16. Dyspnea assessed by mMRC (Modified Medical Research Council) score

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on mMRC (Modified Medical Research Council) score into a value ranging from the least severe dyspnea 0 to the most serious dyspnea 4

    Measured: Change from baseline at 3 months

  17. Exacerbation rate

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on respiratory exacerbation rate

    Measured: After 3 months of use

  18. First exacerbation

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on the time to onset of the first exacerbation.

    Measured: During 3 months of use

  19. Hospitalization rate

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization rate for respiratory exacerbation

    Measured: After 3 months of use

  20. Hospitalization duration

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization duration for respiratory exacerbation

    Measured: After 3 months of use

  21. Antibiotic therapy

    Compare the effect of SIMEOX autonomous treatment at home versus usual care on antibiotic therapy rate (intravenous or oral)

    Measured: After 3 months of use

  22. Adherence telemonitoring feasibility

    Adherence telemonitoring feasibility is assessed by comparing self-declared data (number of treatment session) and electronically transmitted data. Electronically transmitted data will be transmitted by the SIMEOX-ANDROID application to an electronic secured platform.

    In the SIMEOX® treated group only.

    Measured: After 3 months of use

  23. Acceptability of SIMEOX-ANDROID application assessed by self-questionnaire AES (acceptability E-SCALE)

    Total score into a value ranging from the worst acceptability 6 to the best acceptability 30 of the self-questionnaire AES (acceptability E-SCALE) in the SIMEOX® treated group to assess the SIMEOX-ANDROID application acceptability

    Measured: After 3 months of use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2019
  2. Study start10 Mar 2020
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

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
Adaptive prospective, randomized, controlled, multicenter trial, with hierarchical sequential analysis.
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04096664
Sponsor's protocol ID
Home-Care SIMEOX®
Acronym
HomeCareSIMEOX
Status last verified
Jun 2025
First submitted
17 Jul 2019
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SIMEOX in people with Pulmonary Cystic Fibrosis, run by Physio-Assist at 20 sites in France.

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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. 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?

Respiratory score of CFQ-R questionnaire (time frame: Change from baseline at 3 months). The study lists 2 primary outcomes in all. 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 NCT04096664.

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 11 Jun 2025.

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