Bollington

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are studying adults with obstructive hypertrophic cardiomyopathy (HCM) who are treated with mavacamten to understand real-world outcomes and treatment patterns in community practices across the United States. The study also aims to explore the experiences of patients and physicians with mavacamten treatment. This research focuses on adults aged 18 years and older with a confirmed diagnosis of obstructive HCM who have been prescribed mavacamten between April 28, 2022, and December 31, 2024. Participants receive mavacamten according to the product label, and the study observes their treatment over time. This includes monitoring the duration of mavacamten use, dose changes, reasons for dose adjustments or interruptions, and any discontinuation of treatment. The study also tracks changes in other therapies used for HCM during the treatment period. The focus is on real-world clinical use rather than experimental administration. Participants are involved through retrospective chart reviews and may also complete patient surveys if they meet additional criteria. Researchers collect data on blood pressure, genetic testing results, family history related to HCM and sudden cardiac death, comorbid conditions, and functional status using the New York Heart Association (NYHA) classification. These assessments occur at baseline and multiple follow-up points up to 24 weeks. The study measures heart function changes, treatment adherence, and clinical outcomes to provide insights into mavacamten's use in everyday medical practice.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.