Union City

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 evaluating the effectiveness and safety of AZD5148, a monoclonal antibody, to prevent the recurrence of Clostridioides difficile infection in adults aged 18 years and older. This Phase IIb clinical trial involves about 230 participants who have recently experienced a qualifying episode of C. difficile infection and have been treated with standard antibacterial drugs. The study aims to understand how well AZD5148 can reduce the chance of the infection returning. Participants will be randomly assigned to receive a single dose of either AZD5148 or a placebo (normal saline). The medication will be given either as an intramuscular injection or an intravenous push, depending on the investigator's choice. The study includes up to two visits for eligibility confirmation and dose administration, including stool sample collection, followed by up to seven planned visits and weekly then monthly follow-ups conducted by site staff. Participants will also complete an electronic diary during the study. Throughout the study, participants will undergo various assessments including stool testing to monitor for infection recurrence, with the main outcome measured being the first recurrence of C. difficile infection within 91 days after treatment. The study staff will maintain regular contact with participants to monitor safety and track adherence. The total duration of participation includes the initial dose administration and the follow-up period of about three months to assess infection recurrence and safety.

Researchers are evaluating the PyloPlus Urea Breath Test System to confirm the effectiveness of treatment for Helicobacter pylori infection after therapy. This Phase 3, multi-center, open-label study includes participants who have been diagnosed and treated for H. pylori within the past 6 months. The study aims to compare the PyloPlus UBT results against other diagnostic tests to verify post-treatment infection status. Participants will be exposed to non-radioactive 13C-Urea with citric acid, and may provide stool samples or undergo endoscopy for Rapid Urease Test and Histology. The PyloPlus UBT Analyzer will measure changes in carbon 13 content in breath samples but results will be blinded to investigators and physicians. Comparators include another Urea Breath Test using Breath ID, Stool Antigen Test, and histology tests from biopsy samples. During the study, participants will undergo diagnostic testing including breath analysis, stool antigen tests, and possibly endoscopic biopsy. Researchers will measure overall percent agreement of the PyloPlus UBT compared to standard tests within 7 days. Safety and data quality will be monitored, and no treatment decisions will be based on the investigational PyloPlus UBT results. The total study participation duration is not explicitly stated.

Researchers are evaluating the effectiveness and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma who are already using medium-dose inhaled corticosteroids combined with long-acting beta2-agonists (ICS-LABA). The study compares this approach to the usual care of increasing inhaled therapy to high-dose ICS-LABA. This is a global, phase 3b, randomized, double-blind, active-controlled trial involving participants with a history of eosinophilic asthma. Participants receive either benralizumab 30 mg by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks, alongside their medium-dose ICS-LABA treatment, or they receive a placebo injection with an increased high-dose ICS-LABA treatment. The study includes a run-in period to monitor compliance with usual asthma treatment and aims to assess adding benralizumab versus stepping up inhaled therapy. During the study, researchers monitor asthma control, lung function, and exacerbations over 48 weeks. Participants complete asthma diaries to track medication adherence and symptoms. The main outcome measured is the annual rate of asthma exacerbations. Safety and adverse events are also closely followed throughout the study period.