Oldsmar

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 if a modified form of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who experience new low back or leg pain due to acute lumbosacral musculoskeletal conditions, including spinal stenosis and sciatica. This is a double-blind, randomized, placebo-controlled Phase 4 study comparing the active drug to a look-alike placebo. The purpose is to measure changes in pain and how it affects physical activity and sleep over one week. Participants will be randomly assigned to receive either metaxalone 640 mg oral tablets along with standard care or a placebo that looks the same but contains no active drug. The study consists of an initial pilot phase followed by a larger phase with more participants to confirm results. Treatments are taken as oral tablets, and participants continue their usual care. During the study, participants will complete surveys on Day 1 before starting treatment and again on Day 7 to report pain levels, pain quality, and how pain affects their physical activity and sleep. Researchers will monitor changes in pain using a Numeric Pain Scale from Day 1 to Day 7. Participants must be able to respond to text or email reminders for surveys. The total study duration for each participant is 7 days of treatment and follow-up.