534:
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
Sunday, March 4, 2018
South Hall A2 (Convention Center)
John C. Messina Jr., PharmD, Iftikhar Hussain, MD, Jennifer L. Carothers, ScD, MBA, Emmanuel M. Mahlis, MD, Ramy A. Mahmoud, MD, MPH
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.