Malmesbury

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the safety and immune response of the MTBVAC vaccine in adolescents and adults aged 12 to 55 years living with or without HIV in South Africa. The study focuses on comparing MTBVAC to the BCG vaccine and is conducted as a Phase 2a clinical trial. Participants are grouped based on HIV status, CD4+ T cell counts, and IGRA status to better understand the vaccine's effects in different subpopulations. The study is divided into two parts, with Part A including two cohorts and Part B having one cohort, each with four groups. Participants are randomized to receive either a single 0.1 mL injection of MTBVAC or BCG vaccine intradermally. Enrollment in the third cohort will begin only if safety criteria are met for the first two cohorts. All participants receive one dose and are followed for 48 weeks to monitor outcomes. Participants will undergo various assessments throughout the study, including monitoring for adverse events up to 48 weeks and evaluating immune cell responses at baseline and weeks 4 and 10. Researchers will track solicited and unsolicited adverse events, serious adverse events, and Grade 3 or higher adverse events. Safety, immune responses, and overall health will be carefully observed through clinical exams, laboratory tests, and questionnaires during the study period.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.