Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

Pulmonary Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095078
• Other study ID #: Ancillary Home-Care SIMEOX
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: January 2022
• Source: Physio-Assist
• Contact: n/a
• 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

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

Sponsors (2)

Lead Sponsor	Collaborator
Physio-Assist	Icadom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Inspiratory capacity	Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group	Change from baseline at 3 months
Secondary	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
Secondary	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