Case Study: How VitaloJAK® turned objective cough frequency into a powerful digital biomarker in cystic fibrosis trials

The VitaloJAK® Cough Monitor (Vitalograph, UK) was deployed in a multicentre, phase 3b, open-label clinical study (VX‑445–126) evaluating the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in adolescents and adults with cystic fibrosis who were previously CFTR‑modulator naïve.

The study followed an initial pilot feasibility study (VX‑445–118), which specifically assessed adherence and usability of wearable cough and activity monitoring technologies in people with CF.