This is a Phase 2 platform research study that is assessing three different investigational medications (versus placebo) for hospitalized adults who have Acute Respiratory Distress Syndrome (ARDS). As a platform study, each of the three treatment groups will receive a different investigational drug (or placebo) depending on the severity of their ARDS. Participants will also receive standard treatment as determined by the treating physician.
This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).
The goal is to evaluate how well etrasimod helps reduce symptoms by week 12 of treatment. This involves determining whether patients experience enough improvement to be considered in remission. The focus is on how the medication performs in everyday, real-world conditions.