Physio-Assist is pleased to announce that the multicentric MUCOSIM clinical trial (NCT04010253) coordinated by Dr Thierry Perez (CHRU Lille) and sponsored by the Fédération Antadir, is currently being recruited. The objective of this prospective randomized trial is to compare the efficacy and safety of the innovative Simeox technology in patients with cystic fibrosis compared to autogenous drainage.
The main criterion is the evolution during a bronchial drainage session (after 3 training sessions) of the total pulmonary resistance measured by airwave oscillometry (AOS, Tremoflo). The secondary criteria are the evolution of lung function (other AOS criteria, spirometry, plethysmography), respiratory symptoms, fatigue after the session, and adverse events.
42 adult patients with a confirmed diagnosis of cystic fibrosis, stable respiratory function (FEV1 between 30 and 70%) and bronchial congestion will be randomized in 6 investigation centers: CF center of Lille; CF center of Lyon; CF center of Nice; CF center of Roscoff ; CF center of Toulouse ; CF center of Amiens.
CPP’s favourable opinion was obtained in June 2019.