5 results
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,…
Primary:To determine the safety, tolerability, and pharmacokinetic (PK) profile of single ascending intravenous (iv) doses and of multiple ascending iv doses of FMX-8 in healthy subjectsSecondary:To evaluate the pharmacodynamics (PD) of FMX-8 in…
To investigate both the clinical and economical(-healthcare evaluation) improvement of BVR using best responder criteria in patients with severe COPD.
The aim of the study is twofold. The first is the impact of the investigational drugs and the registered product on safety, tolerability and the release of vessels studied and compared. The second is the speed with which the investigational drugs…
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…