Home Airway Clearance in CF Patients
- Conditions
- Pulmonary Cystic Fibrosis
- Interventions
- Device: SIMEOX
- Registration Number
- NCT04096664
- Lead Sponsor
- Physio-Assist
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SIMEOX SIMEOX Use the device for 3 months in addition to usual care
- Primary Outcome Measures
Name Time Method Variation of forced expiratory volume in 1 second (FEV1) 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
Respiratory score of CFQ-R questionnaire 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.
- Secondary Outcome Measures
Name Time Method Total score of CFQ-R questionnaire 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.
Forced expiratory flow Change from baseline at 3 months Relative variation of forced expiratory flow in liter per second in the SIMEOX® treated group versus control group
Static lung compliance in Liter Change from baseline at 3 months Relative variation of Static lung compliance in liter in the SIMEOX® treated group versus control group
Exacerbation rate After 3 months of use Compare the effect of SIMEOX autonomous treatment at home versus usual care on respiratory exacerbation rate
First exacerbation 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.
FEV1/ FVC ratio Change from baseline at 3 months Relative variation of FEV1/ FVC ratio in % in the SIMEOX® treated group versus control group.
Pulmonary forced vital capacity (FVC) Change from baseline at 3 months Relative variation of forced vital capacity in liter in the SIMEOX® treated group versus control group.
Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status 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).
Physical activity assessed by step counts and moderate-to-vigorous physical activity 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
Fatigue assessed by VAS (visual analogue scale) 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
Hospitalization rate After 3 months of use Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization rate for respiratory exacerbation
Safety of use assessed by incidence of Treatment-Emergent Adverse Events 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
Acceptability assessed by the number of uses of SIMEOX® device 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.
Static lung compliance in % of predicted value Change from baseline at 3 months Relative variation of Static lung compliance in % of predicted value in the SIMEOX® treated group versus control group
Diffusion capacity for carbon monoxide Change from baseline at 3 months Relative variation of Diffusion capacity for carbon monoxide in % in the SIMEOX® treated group versus control group
Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire 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
Airway resistance 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
Hospitalization duration After 3 months of use Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization duration for respiratory exacerbation
Antibiotic therapy After 3 months of use Compare the effect of SIMEOX autonomous treatment at home versus usual care on antibiotic therapy rate (intravenous or oral)
Adherence telemonitoring feasibility 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.Sleep quality assessed by sleep efficiency and fragmentation 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
Dyspnea assessed by mMRC (Modified Medical Research Council) score 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
Acceptability of SIMEOX-ANDROID application assessed by self-questionnaire AES (acceptability E-SCALE) 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
Trial Locations
- Locations (20)
CHU Amiens Picardie
🇫🇷Amiens, France
CHU Angers
🇫🇷Angers, France
Grenoble University Hospital : pneumo-pediatric department
🇫🇷Grenoble, France
CHI Créteil
🇫🇷Créteil, France
Grenoble University-Affiliated Hospital : Pneumology department
🇫🇷Grenoble, France
CHU Lyon HCL
🇫🇷Lyon, France
Marseille University Hospital - Pneumology department
🇫🇷Marseille, France
Nice University-Affiliated Hospital : Pneumology department
🇫🇷Nice, France
Nice University-Affiliated Hospital : Pneumo-pediatric department
🇫🇷Nice, France
Hôpital Armand-Trousseau
🇫🇷Paris, France
CHU Reims
🇫🇷Reims, France
CHU Toulouse - Hôpital Larrey
🇫🇷Toulouse, France
Fondation Ildys
🇫🇷Roscoff, France
CHU Felix Guyon
🇫🇷Saint-Denis, France
CHU De la Réunion Site SUD
🇫🇷Saint-Pierre, France
Groupement Hospitalier Brocéliande Atlantique
🇫🇷Vannes, France
Montpellier Hospital Center
🇫🇷Montpellier, France
Hôpital Robert Debré
🇫🇷Paris, France
CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant
🇫🇷Saint-Pierre, France
CHU Toulouse pediatric
🇫🇷Toulouse, France