Home Airway Clearance in CF Patients

Pulmonary Cystic Fibrosis Clinical Trial

— HomeCareSIMEOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096664
• Other study ID #: Home-Care SIMEOX®
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Physio-Assist
• Contact: Laura O Borges
• Phone: 0476747703
• Email: l.borges[@]agiradom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pulmonary Cystic Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	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 : Pneumo-pediatric department	Nice
France	Nice University-Affiliated Hospital : Pneumology department	Nice
France	CHU Reims	Reims
France	Fondation Ildys	Roscoff
France	CHU Toulouse - Hôpital Larrey	Toulouse
France	CHU Toulouse pediatric	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Physio-Assist	Icadom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 3 months
Primary	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	Change from baseline at 3 months
Secondary	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.	Change from baseline at 3 months
Secondary	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	During 3 months of use
Secondary	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	After 3 months of use
Secondary	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.	During 3 months of use
Secondary	Pulmonary forced vital capacity (FVC)	Relative variation of forced vital capacity in liter in the SIMEOX® treated group versus control group.	Change from baseline at 3 months
Secondary	FEV1/ FVC ratio	Relative variation of FEV1/ FVC ratio in % in the SIMEOX® treated group versus control group.	Change from baseline at 3 months
Secondary	Forced expiratory flow	Relative variation of forced expiratory flow in liter per second in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Secondary	Static lung compliance in Liter	Relative variation of Static lung compliance in liter in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Secondary	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	Change from baseline at 3 months
Secondary	Airway resistance	Relative variation of Airway resistance in cmH2O per liter per second in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Secondary	Diffusion capacity for carbon monoxide	Relative variation of Diffusion capacity for carbon monoxide in % in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Secondary	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).	Change from baseline at 3 months
Secondary	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	Change from baseline at 3 months
Secondary	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	Change from baseline at 3 months
Secondary	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	During 3 months of use
Secondary	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	Change from baseline at 3 months
Secondary	Exacerbation rate	Compare the effect of SIMEOX autonomous treatment at home versus usual care on respiratory exacerbation rate	After 3 months of use
Secondary	First exacerbation	Compare the effect of SIMEOX autonomous treatment at home versus usual care on the time to onset of the first exacerbation.	During 3 months of use
Secondary	Hospitalization rate	Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization rate for respiratory exacerbation	After 3 months of use
Secondary	Hospitalization duration	Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization duration for respiratory exacerbation	After 3 months of use
Secondary	Antibiotic therapy	Compare the effect of SIMEOX autonomous treatment at home versus usual care on antibiotic therapy rate (intravenous or oral)	After 3 months of use
Secondary	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.	After 3 months of use
Secondary	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	After 3 months of use