Home Airway Clearance in CF Patients

NCT04096664 | Completed DMC

• 1 other identifier: Home-Care SIMEOX®
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 20

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, 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.

Conditions

Pulmonary Cystic Fibrosis

Keywords

bronchial clearance; cystic fibrosis

Outcome Measures

Primary Outcomes (2)

• Respiratory score of CFQ-R questionnaire

  Relative variation in respiratory score of the CFQ-R questionnaire (Cystic Fibrosis Questionnaire -revised version) in the SIMEOX® treated group versus control group. Score range from 0 to 100, with higher score indicating better health.

  Change from baseline at 3 months

• Variation of forced expiratory volume in 1 second (FEV1)

  Relative variation of the forced expiratory volume in 1 second (FEV1) in the SIMEOX® treated group versus control group

  Change from baseline at 3 months

Secondary Outcomes (23)

• Total score of CFQ-R questionnaire

  Change from baseline at 3 months

• Safety of use assessed by incidence of Treatment-Emergent Adverse Events

  During 3 months of use

• Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire

  After 3 months of use

• Acceptability assessed by the number of uses of SIMEOX® device

  During 3 months of use

• Pulmonary forced vital capacity (FVC)

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

You may qualify if:

• 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.

You may not qualify if:

• Patient placed on a transplant waiting list
• Any contraindication to an instrumental bronchial clearance technique
• Patients already own and use SIMEOX at home
• 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

Sponsors & Collaborators

• Physio-Assist: lead
• Icadom: collaborator

Study Sites (20)

CHU Amiens Picardie

Amiens, 80054, France

Location

CHU Angers

Angers, 49993, France

Location

CHI Créteil

Créteil, 94000, France

Location

Grenoble University Hospital : pneumo-pediatric department

Grenoble, 38043, France

Location

Grenoble University-Affiliated Hospital : Pneumology department

Grenoble, 38043, France

Location

CHU Lyon HCL

Lyon, 69495, France

Location

Marseille University Hospital - Pneumology department

Marseille, 13005, 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

Hôpital Armand-Trousseau

Paris, 75012, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

CHU Reims

Reims, 51092, France

Location

Fondation Ildys

Roscoff, 29684, France

Location

CHU Felix Guyon

Saint-Denis, 97400, France

Location

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

Saint-Pierre, 97448, France

Location

CHU De la Réunion Site SUD

Saint-Pierre, 97448, France

Location

CHU Toulouse - Hôpital Larrey

Toulouse, 31059, France

Location

CHU Toulouse pediatric

Toulouse, 31059, France

Location

Groupement Hospitalier Brocéliande Atlantique

Vannes, 56017, 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

• Rebecca Hamidfar, 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: Adaptive prospective, randomized, controlled, multicenter trial, with hierarchical sequential analysis.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: September 20, 2019
• Study Start: March 10, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)