Zawadzkie

Researchers are evaluating treatment outcomes of tezepelumab in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) who are considered eligible for surgery, with or without asthma. This phase IIIb, multicenter, open-label, single-arm study aims to describe changes in participant-reported nasal congestion and sino-nasal symptoms over time. The study involves approximately 60 sites across 10 countries and targets adults diagnosed with CRSwNP for at least 12 months who meet specific severity criteria. Participants will receive subcutaneous injections of tezepelumab at 210 mg doses. The study is divided into three periods: a screening period lasting up to 4 weeks, a treatment period of 24 weeks with visits every 4 weeks, and a safety follow-up period lasting from week 24 to week 36. The treatment duration is up to 24 weeks, during which participants will be monitored regularly. During the study, participants will undergo assessments of nasal congestion and other sino-nasal symptoms using standardized scoring tools. Researchers will measure changes from baseline at week 24. Safety follow-up will continue until week 36 to monitor participant well-being. Total study participation can last up to 40 weeks, including screening, treatment, and follow-up periods.

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.