Home Airway Clearance in CF Patients

Physio-Assist143 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

143

Conditions

Pulmonary Cystic Fibrosis

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (20)

CHU Amiens Picardie

Amiens, France

CHU Angers

Angers, France

CHI Créteil

Créteil, France

Grenoble University Hospital : pneumo-pediatric department

Grenoble, France

Grenoble University-Affiliated Hospital : Pneumology department

Grenoble, France

CHU Lyon HCL

Lyon, France

Marseille University Hospital - Pneumology department

Marseille, France

Montpellier Hospital Center

Montpellier, France

Nice University-Affiliated Hospital : Pneumology department

Nice, France

Nice University-Affiliated Hospital : Pneumo-pediatric department

Nice, France

...and 10 more locations

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline at 3 months

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

Time frame: Change from baseline at 3 months

Secondary Outcomes

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.

Time frame: Change from baseline at 3 months

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

Time frame: During 3 months of use

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

Time frame: After 3 months of use

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.

Time frame: During 3 months of use

Pulmonary forced vital capacity (FVC)

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

Time frame: Change from baseline at 3 months

FEV1/ FVC ratio

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

Time frame: Change from baseline at 3 months

Forced expiratory flow

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

Time frame: Change from baseline at 3 months

Static lung compliance in Liter

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

Time frame: Change from baseline at 3 months

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

Time frame: Change from baseline at 3 months

Airway resistance

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

Time frame: Change from baseline at 3 months

Diffusion capacity for carbon monoxide

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

Time frame: Change from baseline at 3 months

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).

Time frame: Change from baseline at 3 months

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

Time frame: Change from baseline at 3 months

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

Time frame: Change from baseline at 3 months

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

Time frame: During 3 months of use

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

Time frame: Change from baseline at 3 months

Exacerbation rate

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

Time frame: After 3 months of use

First exacerbation

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

Time frame: During 3 months of use

Hospitalization rate

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

Time frame: After 3 months of use

Hospitalization duration

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

Time frame: After 3 months of use

Antibiotic therapy

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

Time frame: After 3 months of use

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.

Time frame: After 3 months of use

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

Time frame: After 3 months of use