Physio-Assist is pleased to announce that the multicenter clinical trial HomeCare Simeox (NCT04096664) coordinated by Dr. B. CAMARA (CHU de Grenoble, FRANCE) is currently recruiting.
This prospective randomized comparative trial in 2 parallel arms is a pragmatic study which aims to compare the efficacy and tolerance of Simeox technology during 3 months of autonomous use at home compared to standard care.
The main criterion is a hierarchical composite endpoint: 1/ evolution of CFQ-R respiratory domain score, and 2/ evolution of FEV1, evaluated at D0 and 3 months at the CF center.
The secondary criteria are the 3-month evolution of global CFQ-R, dyspnea, spirometry data, residual volume and FRC (PFT), EQ5D, physical activity, sleep quality, compliance, patient satisfaction, post-drainage fatigue, exacerbations, hospitalizations, antibiotic treatments, adverse events.
This adaptive RCT will initially enroll 70 cystic fibrosis patients over the age of 14 years who require at least one bronchial drainage session per week. At the end of this phase 1 of recruitment, the sample size will be recalculated. The first participating centers are currently: adult and pediatric CF centers in Grenoble, mixed CF center in Montpellier, and adult and pediatric CF centers in Nice.
The favorable opinion of the Ethic Committee was obtained in October 2019. The protocol has been reviewed by the medical device department of the French HTA agency (Haute Autorité de Santé) with the objective of a subsequent request for homecare coverage.