Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Cystic Fibrosis
• Intervention / Treatment: Device: SIMEOX

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble University-Affiliated Hospital : Pneumology department
  • Grenoble, France, 38043
    • Grenoble University Hospital : pneumo-pediatric department
  • Montpellier, France, 34000
    • Montpellier Hospital Center
  • Nice, France, 06002
    • Nice University-Affiliated Hospital : Pneumology department
  • Nice, France, 06200
    • Nice University-Affiliated Hospital : Pneumo-pediatric department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care
Experimental: SIMEOX; Use the device for 3 months in addition to usual care	Device: SIMEOX; Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary static hyperinflation assessed by residual volume	Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.	Change from baseline at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During 3 months of use
Inspiratory capacity	Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Residual functional capacity (RFC)	Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Total lung capacity (TLC)	Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group	Change from baseline at 3 months

Collaborators and Investigators

• Sponsor: Physio-Assist
• Collaborators: Icadom
• Investigators: Principal Investigator: Boubou Camara, MD, CHUGA

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: cystic fibrosis; bronchial clearance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: Ancillary Home-Care SIMEOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No