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Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

Primary Purpose

Pulmonary Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SIMEOX
Sponsored by
Physio-Assist
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Cystic Fibrosis focused on measuring bronchial clearance, cystic fibrosis

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • one of the 56 first patients of HOME-CARE SIMEOX study
  • same criteria as HOME-CARE SIMEOX study

Exclusion Criteria:

  • same criteria as HOME-CARE SIMEOX study

Sites / Locations

  • Grenoble University Hospital : pneumo-pediatric department
  • Grenoble University-Affiliated Hospital : Pneumology department
  • Montpellier Hospital Center
  • Nice University-Affiliated Hospital : Pneumology department
  • Nice University-Affiliated Hospital : Pneumo-pediatric department

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

Pulmonary static hyperinflation assessed by residual volume
Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.

Secondary Outcome Measures

Use assessed by the duration of use of SIMEOX® device
Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device.
Inspiratory capacity
Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group
Residual functional capacity (RFC)
Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group
Total lung capacity (TLC)
Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group

Full Information

First Posted
September 17, 2019
Last Updated
January 3, 2022
Sponsor
Physio-Assist
Collaborators
Icadom
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1. Study Identification

Unique Protocol Identification Number
NCT04095078
Brief Title
Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )
Official Title
Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

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, postcare, 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
Prospective, randomized, controlled, multicenter trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

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
Pulmonary static hyperinflation assessed by residual volume
Description
Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Use assessed by the duration of use of SIMEOX® device
Description
Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device.
Time Frame
During 3 months of use
Title
Inspiratory capacity
Description
Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group
Time Frame
Change from baseline at 3 months
Title
Residual functional capacity (RFC)
Description
Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group
Time Frame
Change from baseline at 3 months
Title
Total lung capacity (TLC)
Description
Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group
Time Frame
Change from baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: one of the 56 first patients of HOME-CARE SIMEOX study same criteria as HOME-CARE SIMEOX study Exclusion Criteria: same criteria as HOME-CARE SIMEOX study
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
Grenoble University Hospital : pneumo-pediatric department
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Grenoble University-Affiliated Hospital : Pneumology department
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Montpellier Hospital Center
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Nice University-Affiliated Hospital : Pneumology department
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Nice University-Affiliated Hospital : Pneumo-pediatric department
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

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