Westminster

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 compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.