EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis.

Abstract:

BACKGROUND:Inadequate efficacy of current intranasal steroids in chronic rhinosinusitis (CRS) is attributable to ineffective and/or inconsistent drug delivery to target anatomic sites. A new exhalation delivery system with fluticasone (EDS-FLU) may improve outcomes by significantly increasing superior/posterior corticosteroid delivery. A study was conducted to assess the long-term efficacy and safety outcomes of EDS-FLU in individuals with CRS. METHODS:This was a 12-month, multicenter, single-arm study evaluating the safety and efficacy of EDS-FLU 372 μg twice daily in CRS patients (with [n = 34] or without [n = 189] nasal polyps [NP]). Efficacy assessments by serial nasal endoscopy and patient report included: 22-item Sino-Nasal Outcome Test (SNOT-22), NP grade, standardized surgical indicator assessment, Lund-Kennedy score, and Patient Global Impression of Change. Adverse event (AE) evaluations included nasal endoscopy. Additional safety and efficacy outcomes were assessed. RESULTS:Of 223 patients who received EDS-FLU, 96% reported prior corticosteroid use and 29% prior sinus surgery. The EDS-FLU AE profile was similar to conventional intranasal steroids studied in similar populations. Most patients (87%) reported symptom improvement. Through 12 months, mean SNOT-22 scores improved by -21.5 and -21.1 for CRS with and without NP, respectively. Among patients with NP, 54.2% had polyp elimination in at least 1 nostril and 83.3% had ≥1-point improvement in polyp grade. CONCLUSION:Over 1 year of treatment in CRS with and without NP, EDS-FLU 372 μg twice daily was well tolerated and produced improvements across a broad range of objective and subjective measures. EDS-FLU may be a desirable new option for patients with this condition.

authors

Palmer JN,Jacobson KW,Messina JC,Kosik-Gonzalez C,Djupesland PG,Mahmoud RA

doi

10.1002/alr.22141

subject

Has Abstract

pub_date

2018-06-01 00:00:00

eissn

2042-6976

issn

2042-6984

pub_type

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