Fact CheckerSign in

NCT04096664Completed

Home Airway Clearance in CF Patients

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
143 (actual)
First submitted
17 Jul 2019
Start date
10 Mar 2020
Primary completion date
31 Mar 2025
Lead sponsor
Physio-Assist
NCT number
NCT04096664

What you commit to

  • Study type: Interventional
  • Participants enrolled: 143
  • From 10 Mar 2020 to the primary completion date, 31 Mar 2025
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day.
  • Patient placed on a transplant waiting list
  • 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.
  • Initiation of treatment with a CFTR modulator within the last 3 months

Lab values

  • Any contraindication to an instrumental bronchial clearance technique
  • 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.

Other

  • Patients already own and use SIMEOX at home
  • Unavailable patient or patient wishing to move to a different region within three months after inclusion.

Who the study is looking for

  • 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.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Amiens Picardie
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
CHU Angers
Coordinator of this site? Confirm its status
AngersFranceUnknown status
Chi Creteil
Coordinator of this site? Confirm its status
CréteilFranceUnknown status
Grenoble University Hospital : pneumo-pediatric department
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
Grenoble University-Affiliated Hospital : Pneumology department
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
CHU Lyon HCL
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Marseille University Hospital - Pneumology department
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
Montpellier Hospital Center
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Nice University-Affiliated Hospital : Pneumo-pediatric department
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Nice University-Affiliated Hospital : Pneumology department
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Hôpital Armand-Trousseau
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hopital Robert Debre
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU Reims
Coordinator of this site? Confirm its status
ReimsFranceUnknown status
Fondation ILDYS
Coordinator of this site? Confirm its status
RoscoffFranceUnknown status
CHU Felix Guyon
Coordinator of this site? Confirm its status
Saint-DenisFranceUnknown status
CHU de La Réunion-Site Sud
Coordinator of this site? Confirm its status
Saint-PierreFranceUnknown status
CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant
Coordinator of this site? Confirm its status
Saint-PierreFranceUnknown status
CHU Toulouse - Hopital Larrey
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
CHU Toulouse pediatric
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Groupement Hospitalier Brocéliande Atlantique
Coordinator of this site? Confirm its status
VannesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.