Roodepoort

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.

This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.