Back to resultsHome Airway Clearance in CF Patients (HomeCareSIMEOX)
Primary Purpose
Pulmonary Cystic Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SIMEOX
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Cystic Fibrosis focused on measuring bronchial clearance, cystic fibrosis
Eligibility Criteria
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 >14
- 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.
Sites / Locations
- CHU Amiens Picardie
- Grenoble University Hospital : pneumo-pediatric departmentRecruiting
- Grenoble University-Affiliated Hospital : Pneumology departmentRecruiting
- Marseille University Hospital - Pneumology departmentRecruiting
- Montpellier Hospital Center
- Nice University-Affiliated Hospital : Pneumology departmentRecruiting
- Nice University-Affiliated Hospital : Pneumo-pediatric department
- Fondation IldysRecruiting
- CHU Toulouse - Hôpital LarreyRecruiting
- CHU Toulouse pediatric
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SIMEOX
Control
Arm Description
Use the device for 3 months in addition to usual care
Usual care
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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
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
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.
Pulmonary forced vital capacity (FVC)
Relative variation of forced vital capacity in liter in the SIMEOX® treated group versus control group.
FEV1/ FVC ratio
Relative variation of FEV1/ FVC ratio in % in the SIMEOX® treated group versus control group.
Forced expiratory flow
Relative variation of forced expiratory flow in liter per second in the SIMEOX® treated group versus control group
Static lung compliance in Liter
Relative variation of Static lung compliance in liter in the SIMEOX® treated group versus control group
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
Airway resistance
Relative variation of Airway resistance in cmH2O per liter per second in the SIMEOX® treated group versus control group
Diffusion capacity for carbon monoxide
Relative variation of Diffusion capacity for carbon monoxide in % 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
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
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
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
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
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
Exacerbation rate
Compare the effect of SIMEOX autonomous treatment at home versus usual care on respiratory exacerbation rate
First exacerbation
Compare the effect of SIMEOX autonomous treatment at home versus usual care on the time to onset of the first exacerbation.
Hospitalization rate
Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization rate for respiratory exacerbation
Hospitalization duration
Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization duration for respiratory exacerbation
Antibiotic therapy
Compare the effect of SIMEOX autonomous treatment at home versus usual care on antibiotic therapy rate (intravenous or oral)
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.
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
Full Information
NCT ID
NCT04096664
First Posted
July 17, 2019
Last Updated
October 4, 2022
Sponsor
Physio-Assist
Collaborators
Icadom
1. Study Identification
Unique Protocol Identification Number
NCT04096664
Brief Title
Home Airway Clearance in CF Patients
Acronym
HomeCareSIMEOX
Official Title
Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physio-Assist
Collaborators
Icadom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Cystic Fibrosis
Keywords
bronchial clearance, cystic fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adaptive prospective, randomized, controlled, multicenter trial, with hierarchical sequential analysis.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SIMEOX
Arm Type
Experimental
Arm Description
Use the device for 3 months in addition to usual care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
SIMEOX
Intervention Description
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
Primary Outcome Measure Information:
Title
Respiratory score of CFQ-R questionnaire
Description
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
Title
Variation of forced expiratory volume in 1 second (FEV1)
Description
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 Outcome Measure Information:
Title
Total score of CFQ-R questionnaire
Description
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
Title
Safety of use assessed by incidence of Treatment-Emergent Adverse Events
Description
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
Title
Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire
Description
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
Title
Acceptability assessed by the number of uses of SIMEOX® device
Description
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
Title
Pulmonary forced vital capacity (FVC)
Description
Relative variation of forced vital capacity in liter in the SIMEOX® treated group versus control group.
Time Frame
Change from baseline at 3 months
Title
FEV1/ FVC ratio
Description
Relative variation of FEV1/ FVC ratio in % in the SIMEOX® treated group versus control group.
Time Frame
Change from baseline at 3 months
Title
Forced expiratory flow
Description
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
Title
Static lung compliance in Liter
Description
Relative variation of Static lung compliance in liter in the SIMEOX® treated group versus control group
Time Frame
Change from baseline at 3 months
Title
Static lung compliance in % of predicted value
Description
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
Title
Airway resistance
Description
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
Title
Diffusion capacity for carbon monoxide
Description
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
Title
Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status
Description
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
Title
Physical activity assessed by step counts and moderate-to-vigorous physical activity
Description
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
Title
Sleep quality assessed by sleep efficiency and fragmentation
Description
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
Title
Fatigue assessed by VAS (visual analogue scale)
Description
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
Title
Dyspnea assessed by mMRC (Modified Medical Research Council) score
Description
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
Title
Exacerbation rate
Description
Compare the effect of SIMEOX autonomous treatment at home versus usual care on respiratory exacerbation rate
Time Frame
After 3 months of use
Title
First exacerbation
Description
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
Title
Hospitalization rate
Description
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
Title
Hospitalization duration
Description
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
Title
Antibiotic therapy
Description
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
Title
Adherence telemonitoring feasibility
Description
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
Title
Acceptability of SIMEOX-ANDROID application assessed by self-questionnaire AES (acceptability E-SCALE)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 >14
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura O Borges
Phone
0476747703
Ext
+33
Email
l.borges@agiradom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christian Borel, PHD
Phone
04.56.38.86.56
Ext
+33
Email
j.borel@agiradom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boubou Camara, MD
Organizational Affiliation
CHUGA
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Andrejak, MD
Email
Andrejak.Claire@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Zouhair Bachour
Email
Bachour.Zouhair@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Claire Poulet, MD
Facility Name
Grenoble University Hospital : pneumo-pediatric department
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle PIN, MD
Email
IPin@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Caroline TOURNEGROS
Email
Ctournegros@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Isabelle PIN, MD
First Name & Middle Initial & Last Name & Degree
Cathy LLERENA, MD
Facility Name
Grenoble University-Affiliated Hospital : Pneumology department
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boubou Camara, MD
Phone
+33 476765846
Email
bcamara@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Marie Jondot
Email
mjondot@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Boubou Camara, MD
First Name & Middle Initial & Last Name & Degree
Sebastien Quetant, MD
Facility Name
Marseille University Hospital - Pneumology department
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine Melis
Phone
+33491966139
Email
amandine.melis@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Bérengère Coltey, MD
First Name & Middle Initial & Last Name & Degree
Nadine Dufeu, MD
Facility Name
Montpellier Hospital Center
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Suspended
Facility Name
Nice University-Affiliated Hospital : Pneumology department
City
Nice
ZIP/Postal Code
06002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Griffonnet
Phone
+33 4 92 03 82 81
Email
griffonnet.j@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Sylvie Leroy, MD
First Name & Middle Initial & Last Name & Degree
Johana Pradelli, MD
First Name & Middle Initial & Last Name & Degree
Michèle Benhayoun, MD
Facility Name
Nice University-Affiliated Hospital : Pneumo-pediatric department
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline Joulie
Phone
+33492030520
Email
joulie.a@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Carole Piccini Bailly, MD
Facility Name
Fondation Ildys
City
Roscoff
ZIP/Postal Code
29684
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie RAMEL, MD
Email
sophie.ramel@ildys.org
First Name & Middle Initial & Last Name & Degree
Jocelyne PENGAM
Email
jocelyne.pengam@ildys.org
Facility Name
CHU Toulouse - Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène MURRIS, MD
Email
murris.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Aurore KOMPERDRA
Email
komperdra.a@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Marion DUPUIS, MD
Facility Name
CHU Toulouse pediatric
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurène ROUSSEL, MD
Email
roussel.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Amelie ARROUY
Email
arrouy.a@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Home Airway Clearance in CF Patients
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