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
- Diseases
- Cystic fibrosis
- 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
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Chi Creteil Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Grenoble University Hospital : pneumo-pediatric department Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Grenoble University-Affiliated Hospital : Pneumology department Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CHU Lyon HCL Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Marseille University Hospital - Pneumology department Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Montpellier Hospital Center Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Nice University-Affiliated Hospital : Pneumo-pediatric department Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Nice University-Affiliated Hospital : Pneumology department Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital Armand-Trousseau Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Robert Debre Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Fondation ILDYS Coordinator of this site? Confirm its status | Roscoff | France | Unknown status |
| CHU Felix Guyon Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| CHU de La Réunion-Site Sud Coordinator of this site? Confirm its status | Saint-Pierre | France | Unknown status |
| CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant Coordinator of this site? Confirm its status | Saint-Pierre | France | Unknown status |
| CHU Toulouse - Hopital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU Toulouse pediatric Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Groupement Hospitalier Brocéliande Atlantique Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.