Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

NCT04095078 | Completed DMC

• 1 other identifier: Ancillary Home-Care SIMEOX
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

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.

Conditions

Pulmonary Cystic Fibrosis

Keywords

bronchial clearance; cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Use assessed by the duration of use of SIMEOX® device

  During 3 months of use

• Inspiratory capacity

  Change from baseline at 3 months

• Residual functional capacity (RFC)

  Change from baseline at 3 months

• Total lung capacity (TLC)

  Change from baseline at 3 months

Study Arms (2)

SIMEOX

EXPERIMENTAL

Use the device for 3 months in addition to usual care

Device: SIMEOX

Control

NO INTERVENTION

Usual care

Interventions

SIMEOX DEVICE

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

SIMEOX

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• same criteria as HOME-CARE SIMEOX study

Sponsors & Collaborators

• Physio-Assist: lead
• Icadom: collaborator

Study Sites (5)

Grenoble University Hospital : pneumo-pediatric department

Grenoble, 38043, France

Location

Grenoble University-Affiliated Hospital : Pneumology department

Grenoble, 38043, France

Location

Montpellier Hospital Center

Montpellier, 34000, France

Location

Nice University-Affiliated Hospital : Pneumology department

Nice, 06002, France

Location

Nice University-Affiliated Hospital : Pneumo-pediatric department

Nice, 06200, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Boubou Camara, MD

  CHUGA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, multicenter trial

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: March 10, 2020
• Primary Completion: September 15, 2021
• Study Completion: December 15, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)