Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
Efficacy of Exhalation Delivery System With Fluticasone in Chronic Rhinosinusitis With Versus Without Polyps.
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Schlosser Rodney J, Adappa Nithin D, Chandra Rakesh K, Davis Greg E, Mahdavinia Mahboobeh, Messina John, Patel Zara M, Peters Anju T, Sindwani Raj, Soler Zachary M, White Andrew A, Wise Sarah K, Palmer James N
Аннотация
OBJECTIVE: To evaluate whether treatment responses to the exhalation delivery system with fluticasone (EDS-FLU; XHANCE®) differ between patients with CRS with nasal polyps (CRSwNP) and patients without nasal polyps (CRSsNP).
STUDY DESIGN: Post hoc analysis of the ReOpen clinical trials conducted between November 2018 and November 2021 for a 24-week duration.
SETTING: Multinational, multicenter, randomized, EDS-placebo-controlled studies.
METHODS: Data were pooled from the randomized trials in which patients with CRSwNP (n = 206) or CRSsNP (n = 341) were randomly assigned (1:1:1) to EDS-FLU 186 μg, 372 μg, or EDS-placebo, 1 or 2 sprays twice daily per nostril for 24 weeks. Endpoints included composite symptom score, Smell Identification Test (SIT), sinus opacification on computed tomography (CT) scan, frequency of acute exacerbations of CRS, 22-Item Sino-Nasal Outcome Test (SNOT-22), and Patient Global Impression of Change (PGIC).
RESULTS: Patients with CRSwNP and CRSsNP reported substantially greater benefits with EDS-FLU versus EDS-placebo on symptoms, SIT, sinus opacification on CT scan, incidence of acute exacerbations of CRS, and quality-of-life outcomes (SNOT-22 and PGIC). Composite symptom score and SNOT-22 improvements were consistent in the subgroup of patients entering the trial reporting symptoms despite recent standard-delivery nasal steroid spray use. Treatment-by-subgroup interaction effects indicated similar magnitude EDS-FLU treatment effect for patients with CRSwNP and patients with CRSsNP.
CONCLUSION: EDS-FLU improved subjective and objective measures of CRS irrespective of nasal polyp status.
TRIAL REGISTRATION: Title: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps; ID: NCT03781804 and NCT03960580, Clinicaltrials.gov.
STUDY DESIGN: Post hoc analysis of the ReOpen clinical trials conducted between November 2018 and November 2021 for a 24-week duration.
SETTING: Multinational, multicenter, randomized, EDS-placebo-controlled studies.
METHODS: Data were pooled from the randomized trials in which patients with CRSwNP (n = 206) or CRSsNP (n = 341) were randomly assigned (1:1:1) to EDS-FLU 186 μg, 372 μg, or EDS-placebo, 1 or 2 sprays twice daily per nostril for 24 weeks. Endpoints included composite symptom score, Smell Identification Test (SIT), sinus opacification on computed tomography (CT) scan, frequency of acute exacerbations of CRS, 22-Item Sino-Nasal Outcome Test (SNOT-22), and Patient Global Impression of Change (PGIC).
RESULTS: Patients with CRSwNP and CRSsNP reported substantially greater benefits with EDS-FLU versus EDS-placebo on symptoms, SIT, sinus opacification on CT scan, incidence of acute exacerbations of CRS, and quality-of-life outcomes (SNOT-22 and PGIC). Composite symptom score and SNOT-22 improvements were consistent in the subgroup of patients entering the trial reporting symptoms despite recent standard-delivery nasal steroid spray use. Treatment-by-subgroup interaction effects indicated similar magnitude EDS-FLU treatment effect for patients with CRSwNP and patients with CRSsNP.
CONCLUSION: EDS-FLU improved subjective and objective measures of CRS irrespective of nasal polyp status.
TRIAL REGISTRATION: Title: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps; ID: NCT03781804 and NCT03960580, Clinicaltrials.gov.