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Completed

NCT Number: NCT04096664

Home Airway Clearance in CF Patients

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.

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Key information

Conditions

Pulmonary Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Simeox

Device

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

Primary outcomes

  1. Respiratory score of CFQ-R questionnaire

    Time frame: Change from baseline at 3 months

    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.

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

    Time frame: Change from baseline at 3 months

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

Secondary outcomes

  1. Total score of CFQ-R questionnaire

    Time frame: Change from baseline at 3 months

    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.

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

    Time frame: During 3 months of use

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

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

    Time frame: After 3 months of use

    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

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

    Time frame: During 3 months of use

    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.

  5. Pulmonary forced vital capacity (FVC)

    Time frame: Change from baseline at 3 months

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

  6. FEV1/ FVC ratio

    Time frame: Change from baseline at 3 months

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

  7. Forced expiratory flow

    Time frame: Change from baseline at 3 months

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

  8. Static lung compliance in Liter

    Time frame: Change from baseline at 3 months

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

  9. Static lung compliance in % of predicted value

    Time frame: Change from baseline at 3 months

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

  10. Airway resistance

    Time frame: Change from baseline at 3 months

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

  11. Diffusion capacity for carbon monoxide

    Time frame: Change from baseline at 3 months

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

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

    Time frame: Change from baseline at 3 months

    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).

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

    Time frame: Change from baseline at 3 months

    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

  14. Sleep quality assessed by sleep efficiency and fragmentation

    Time frame: Change from baseline at 3 months

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

  15. Fatigue assessed by VAS (visual analogue scale)

    Time frame: During 3 months of use

    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

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

    Time frame: Change from baseline at 3 months

    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

  17. Exacerbation rate

    Time frame: After 3 months of use

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

  18. First exacerbation

    Time frame: During 3 months of use

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

  19. Hospitalization rate

    Time frame: After 3 months of use

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

  20. Hospitalization duration

    Time frame: After 3 months of use

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

  21. Antibiotic therapy

    Time frame: After 3 months of use

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

  22. Adherence telemonitoring feasibility

    Time frame: After 3 months of use

    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.

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

    Time frame: After 3 months of use

    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

Sponsors and collaborators

Lead sponsor

Physio-Assist

Industry

Collaborators

  • Icadom

Registry information

Official study title

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

Acronym: HomeCareSIMEOX

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2019
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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