Feldbach

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.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are investigating the effect of high-dose vitamin D3 on mortality in adult critically ill patients, particularly those with severe vitamin D deficiency. Previous studies found no benefit in hospital length of stay but suggested a significant reduction in 28-day mortality in patients with very low vitamin D levels. This phase III randomized controlled trial aims to confirm these findings in a larger, multicenter setting. Participants will be randomly assigned to receive either a high dose of vitamin D3 or a placebo. The vitamin D3 group will get an oral loading dose of 540,000 IU dissolved in 37.5 ml of medium chain triglycerides MCT, followed by 4000 IU daily 10 drops for 90 days. The placebo group will receive an identical MCT loading dose and daily drops for the same duration. The study features a double-blind design and an interim analysis after half of the planned patients complete 28 days. During the study, participants will be monitored for 28-day mortality as the primary outcome. Secondary outcomes include hospital length of stay, hypercalcemia at day 5, and hospital readmissions within 90 days. The study involves regular assessments, safety monitoring by an independent board, and continued enrollment while interim analyses are conducted. Total participation spans at least 90 days with detailed follow-up.