Status:
COMPLETED
Home Airway Clearance in CF Patients
Lead Sponsor:
Physio-Assist
Collaborating Sponsors:
Icadom
Conditions:
Pulmonary Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04096664
Start Date
March 10 2020
End Date
March 31 2025
Last Update
June 11 2025
Active Locations (20)
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1
CHU Amiens Picardie
Amiens, France, 80054
2
CHU Angers
Angers, France, 49993
3
CHI Créteil
Créteil, France, 94000
4
Grenoble University Hospital : pneumo-pediatric department
Grenoble, France, 38043