Home Airway Clearance in CF Patients

Last updated: August 19, 2024
Sponsor: Physio-Assist
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

SIMEOX

Clinical Study ID

NCT04096664
Home-Care SIMEOX®
  • Ages > 12
  • All Genders

Study 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, 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient diagnosed with Cystic fibrosis

  • Stabilization of the disease, defined by an at least 4 weeks period since the end ofan exacerbation, stabilization will be let to investigator's judgment.

  • Age >12

  • Requiring at least 1 bronchial clearing session each week (regardless of thetechnique)

  • Patient (or patient's legal representative if applicable), capable to read andunderstand the procedure, and capable to express consent for the study protocol.

Exclusion

Exclusion Criteria:

  • Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeksbefore 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 threemonths after inclusion.

  • Patient currently participating or having participated to another interventionalclinical 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 theserum human chorionic gonadotropin level for any woman wishing to enter the protocoland under childbearing age < 60), parturient woman, breastfeeding mother, everyonedeprived of his liberty by judicial or administrative decision, everyone subject toa legal protection measure.

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

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: SIMEOX
Phase:
Study Start date:
March 10, 2020
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • CHU Amiens Picardie

    Amiens, 80054
    France

    Active - Recruiting

  • CHU Angers

    Angers, 49993
    France

    Active - Recruiting

  • CHI Créteil

    Créteil, 94000
    France

    Active - Recruiting

  • Grenoble University Hospital : pneumo-pediatric department

    Grenoble, 38043
    France

    Active - Recruiting

  • Grenoble University-Affiliated Hospital : Pneumology department

    Grenoble, 38043
    France

    Active - Recruiting

  • CHU Lyon HCL

    Lyon, 69495
    France

    Active - Recruiting

  • Marseille University Hospital - Pneumology department

    Marseille, 13005
    France

    Completed

  • Montpellier Hospital Center

    Montpellier, 34000
    France

    Suspended

  • Nice University-Affiliated Hospital : Pneumo-pediatric department

    Nice, 06200
    France

    Active - Recruiting

  • Nice University-Affiliated Hospital : Pneumology department

    Nice, 06002
    France

    Active - Recruiting

  • Hôpital Armand-Trousseau

    Paris, 75012
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

  • CHU Reims

    Reims, 51092
    France

    Active - Recruiting

  • Fondation Ildys

    Roscoff, 29684
    France

    Active - Recruiting

  • CHU Felix Guyon

    Saint-Denis, 97400
    France

    Active - Recruiting

  • CHU De la Réunion Site SUD

    Saint-Pierre, 97448
    France

    Active - Recruiting

  • CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant

    Saint-Pierre, 97448
    France

    Active - Recruiting

  • CHU Toulouse - Hôpital Larrey

    Toulouse, 31059
    France

    Active - Recruiting

  • CHU Toulouse pediatric

    Toulouse, 31059
    France

    Completed

  • Groupement Hospitalier Brocéliande Atlantique

    Vannes, 56017
    France

    Active - Recruiting

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