5 results
The purpose of this study is to assess the safety and effectiveness of bronchoscopic lung volume reduction (BLVR) using the PulmonxEndobronchial Valve (EBV) in treated study participants compared to control participants to support a premarket…
To investigate both the clinical and economical(-healthcare evaluation) improvement of BVR using best responder criteria in patients with severe COPD.
Primary objective:To evaluate pulmonary function (FEV1) at 3 months following placement of Zephyr endobronchial valves in subjects with homogeneous emphysema.Secondary objectives:Evaluation of quality of life, exercise capacity, dyspnea incl. BODE,…
In this study, we want to investigate the effect of the change in co-medication from lumacaftor to tezacaftor on the kinetics and exposure levels of ivacaftor described by the through concentrationsPrimary Objective: - the through concentration of…
Primary objective: - To evaluate the efficacy of VX-445/TEZ/IVA in CF subjects who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).Secondary objectives: - To evaluate the safety of VX-445/TEZ/IVA- To…