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Home Airway Clearance in CF Patients (HomeCareSIMEOX)

P

PhysioAssist

Status

Enrolling

Conditions

Pulmonary Cystic Fibrosis

Treatments

Device: SIMEOX

Study type

Interventional

Funder types

Industry

Identifiers

NCT04096664
Home-Care SIMEOX®

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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 >12
  • 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.
  • Initiation of treatment with a CFTR modulator within the last 3 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

SIMEOX
Experimental group
Description:
Use the device for 3 months in addition to usual care
Treatment:
Device: SIMEOX
Control
No Intervention group
Description:
Usual care

Trial contacts and locations

20

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Central trial contact

Jean-Christian Borel, PHD; Laura O Borges

Data sourced from clinicaltrials.gov

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