Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis The 'Real World' Study of Smell Changes with Dupilumab in Chronic Rhinosinusitis with Nasal Polyps

What this Trial Is About

Researchers are evaluating the effect of dupilumab treatment on the sense of smell in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The study focuses on measuring changes in the olfactory TDI score, which includes threshold, discrimination, and identification abilities using the Sniffin' sticks test. The trial is a Phase 4 study following 27 adult patients receiving dupilumab treatment over six months. Participants receive dupilumab as a subcutaneous injection, starting with an initial 600 mg dose followed by five 300 mg doses every four weeks for a total of six months. There are three scheduled visits to the Otolaryngology Clinic: at baseline, 3 months, and 6 months during treatment. The primary measure is the change in the TDI score at 12 and 24 weeks. Secondary measures include the nasal polyp score, Quality of Olfactory Disorders negative symptom scores, and SNOT-22. During the study, participants will undergo evaluations of their sense of smell using the Sniffin' sticks test at the three visits. Researchers will collect data on olfactory function and nasal symptoms to assess treatment effects. The total participation period spans six months, with monitoring at baseline, three months, and six months to observe changes over time and ensure safety.

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis