Union City

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the efficacy and safety of AZD5148, a monoclonal antibody, for preventing the recurrence of Clostridioides difficile infection in adults aged 18 and older. This Phase IIb study aims to compare a single dose of AZD5148 with a placebo to better understand its potential role in reducing recurrent infections. The study involves approximately 230 participants randomized equally to receive either the active drug or placebo. Participants will receive one dose of AZD5148 or placebo, administered either by intramuscular injection or intravenous push based on the investigators choice. The study includes up to two site visits for eligibility confirmation and dose administration, including stool sample collection. Following treatment, there will be up to seven planned visits with weekly contacts initiated by the study staff, transitioning later to monthly follow-ups. Participants will also complete an electronic diary to record relevant information. During the study, participants will undergo various assessments including stool testing, monitoring of diarrhea symptoms, and evaluation of any recurrence of infection up to 91 days after dosing. Safety assessments will include monitoring for immediate and delayed adverse events, injection site reactions, and serious adverse events up to 361 days. Pharmacokinetics and immune response to AZD5148 will also be evaluated. The total participation period spans from initial screening through follow-up visits extending up to nearly one year after treatment.

Researchers are evaluating the PyloPlus Urea Breath Test System to confirm the effectiveness of treatment for Helicobacter pylori infection. This multi-center, non-randomized, open-label study includes patients who have been treated for H. pylori within the past six months and aims to compare the PyloPlus system results with other diagnostic methods. The study is sponsored by ARJ Medical, Inc. and is conducted in a Phase 3 setting. Participants will undergo testing with the PyloPlus UBT System, which measures carbon-13 content in breath after ingesting a special urea compound. In addition, patients may have stool antigen testing and a comparator breath test or undergo an endoscopy for rapid urease testing and histology as diagnostic comparisons. The PyloPlus test results are kept blinded from treating physicians, who will manage patient care independently. During the study, participants will provide breath samples analyzed by the PyloPlus UBT Analyzer and may submit stool samples or undergo endoscopy with biopsy. The main outcome measured is the overall percent agreement of the PyloPlus test results compared to standard diagnostic tests within seven days. The study includes safety monitoring and does not influence clinical management decisions based on the investigational test results.

This trial investigates the efficacy and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma. These participants are already treated with a medium-dose inhaled corticosteroid and long-acting beta2-agonist ICS-LABA. The study compares adding benralizumab to increasing the inhaled therapy to a higher dose ICS-LABA. The research is a randomized, double-blind, active-controlled phase 3b trial designed to evaluate these treatments in people with a history of eosinophilic asthma who remain uncontrolled on medium-dose ICS-LABA with or without other controllers except oral corticosteroids. Participants are randomly assigned to one of two groups one receives benralizumab 30 mg by subcutaneous injection along with medium-dose ICS-LABA, and the other receives a placebo injection plus high-dose ICS-LABA. Doses of benralizumab or placebo are given every 4 weeks for the first three doses, then every 8 weeks, with up to seven injections during the study. The study treatment schedules continue for 48 weeks. During the study, participants will undergo assessments including lung function tests, asthma control questionnaires, and quality of life surveys. Researchers will track the annual rate of asthma exacerbations, time to first exacerbation, and safety events throughout the 48-week period. Compliance with asthma controller medication is monitored via daily diaries. This comprehensive evaluation helps understand the impact of adding benralizumab compared to increasing inhaled therapy dose in uncontrolled eosinophilic asthma.