Lawrence Township

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 developing and validating a single-gene Non-Invasive Prenatal Test (sgNIPT) to detect serious health conditions in unborn babies. This test focuses on conditions such as cystic fibrosis, spinal muscular atrophy, sickle cell disease, alpha thalassemia, and beta thalassemia. The goal is to provide information about the possibility that a child will be born with one of these disorders, even when reproductive partner screening is not available or prenatal diagnostic testing is not an option. The study evaluates the investigational sgNIPT device, which is intended for pregnant people whose fetus or fetuses are at increased risk for a single-gene disorder. This includes cases where there is no paternal screening, positive partner screening but no prenatal diagnostic testing available, or concern based on fetal ultrasound findings. Participants will have blood samples collected at 9 or more weeks of pregnancy, and newborn cheek swabs will be collected within six months after delivery. During the study, researchers will collect medical information from pregnant women and, in some cases, their reproductive partners. They will also gather genetic testing results or cheek swab samples from newborns. The main outcome measured is the performance of the sgNIPT assay in detecting the targeted single-gene disorders, with results expected about two years after the study launch. Participants will be monitored through blood draws, ultrasound findings, and newborn tests to assess the test's accuracy and safety.