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.
This study gives people who were part of an earlier Avalyn research protocol with inhaled pirfenidone versus placebo an opportunity to convert to open label or active investigational drug treatment. The goal is to continue learning additional safety and efficacy information in patients over a longer period of treatment time. Pulmonary fibrosis is a disorder with a poor prognosis that is often far worse than many cancers with limited treatment options. While this medication has yet to be proven effective, the safety profile currently is acceptable and the risks versus benefits favor offering this opportunity to patients with informed consent.
This study will see if the experimental medicine MTX-463 can slow or stop idiopathic pulmonary fibrosis (IPF) from worsening in people at least 40 years of age or older. Participants will receive either MTX-463 or a placebo (which contains no active drug) through an intravenous infusion once every 4 weeks, for a total of 6 infusions. Overall, participants will attend a total of 9 visits over the course of approximately 32 weeks, or roughly 8 months.
The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.