Vestal

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

Researchers are evaluating treatments for knee osteoarthritis, focusing on the effects of intra-articular injections of ketorolac, cortisone, and their combination. Cortisone injections are commonly used but have known side effects, including tissue damage near the injection site and faster joint degeneration. Ketorolac, a non-steroidal anti-inflammatory drug usually injected into muscles, is gaining interest as an alternative or addition to cortisone for knee injections, but limited data exists comparing these options in controlled trials. Participants will receive a single injection of either ketorolac 30 mg, triamcinolone 40 mg (a cortisone), or a combination of both into the affected knee joint. The medications are prepared and administered in a blinded, randomized manner. The study involves one injection at the time of enrollment and no further treatment during the study period. Participants will complete surveys about their knee symptoms before the injection and at 1 week, 6 weeks, 12 weeks, and if needed, 24 weeks after the injection. The study measures changes in patient-reported outcomes using the Modified KOOS (Knee injury and Osteoarthritis Outcome Score) to evaluate whether ketorolac alone or combined with cortisone improves symptoms better than cortisone alone. Safety and effectiveness will be monitored throughout the 24-week period.