Exhalation Delivery System with Fluticasone (EDS-FLU) Improves Outcomes in Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) in Patients With or Without Recent Intranasal Steroid Use

RATIONALE: Systemic steroids significantly reduce inflammation and symptoms in CRSsNP, but have a poor safety profile. Multiple guidelines recommend topical intranasal steroids (INS), but efficacy is frequently unsatisfactory with currently available steroid nasal sprays (regardless of steroid molecule). EDS-FLU is different because it delivers steroid to sites high/deep in the nose, including where sinus ostia drain/ventilate. We report EDS-FLU treatment outcomes for CRSsNP patients with and without a recent INS.

METHODS: We analyzed CRSsNP data from two, multicenter, single-arm studies (n=898), EXHANCE-3 (12 weeks) and EXHANCE-12 (52 weeks) where patients received EDS-FLU 372µg BID. Multiple objective, subjective, quality of life and safety outcomes were examined. Sinonasal Outcomes Test (SNOT-22), Lund-Kennedy endoscopic edema assessment and Patient Global Impression of Change (PGIC) are reported by prior INS use (+INS=use ≤30 days before randomization or -INS=no use within 30 days).

RESULTS: At study end, SNOT-22 improved by 22.1 and 19.5 (+INS) and 28.4 and 18.8 (-INS) in EXHANCE- 3 and -12, respectively. Among patients with nasal edema at baseline, 53% and 58.6% (+INS) and 50% and 41.2% (-INS) achieved resolution of edema by end-of-study in EXHANCE-3 and -12, respectively. In EXHANCE-3/12, 68.1%/74.5% +INS compared with 70.7%/66.7% -INS, respectively, reported being ‘much’ or very much improved on PGIC.

CONCLUSIONS: EDS-FLU improved objective and subjective measures of disease and quality-of-life similarly in CRSsNP who had or had not recently used currently available INS. These data suggest EDS-FLU could play an important role in patients who do not adequately respond to currently available INS.