Elizabeth City

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 the outpatient use of Teclistamab or Talquetamab in adults with relapsed or refractory multiple myeloma (RRMM). This phase II, three-arm, non-randomized, multicenter study investigates the safety and management of these treatments, particularly focusing on reducing cytokine release syndrome (CRS) through prophylactic use of tocilizumab or dexamethasone. Teclistamab targets the CD3 receptor on T cells and BCMA on B-lineage cells, while Talquetamab targets CD3 and GPRC5D on myeloma cells. Participants receive Teclistamab or Talquetamab via subcutaneous injections with step-up doses in the first cycle, followed by maintenance dosing weekly or every two to four weeks depending on response. Tocilizumab or oral dexamethasone is given as pretreatment to reduce CRS risk. Teclistamab is dosed on Days 1, 4, and 8 initially, then weekly; dosing may be spaced out after six months of response. Talquetamab is dosed on Days 1, 4, 8, and 15 initially, then every two weeks; dosing may be spaced out after Cycle 4. Participants must stay close to the treatment site and be monitored closely during the first two cycles, including twice daily recordings of temperature and oxygen levels. Safety visits and assessments are conducted regularly. The main outcome measured is the occurrence of CRS during the first two treatment cycles. Participants are educated about potential side effects and monitored with support from a companion to recognize symptoms early.