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

Author

Palmer, James N., Jacobson, Kraig W., Messina, John C., Kosik‐Gonzalez, Colette, Djupesland, Per G., and Mahmoud, Ramy A.

Subjects
nasal inflammation, corticosteroid, nasal polyps, chronic rhinosinusitis, nasal congestion, otorhinolaryngologic diseases, sinus surgery, Original Article, Original Articles, intranasal steroid
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.

Published
2018

11. Supplemental material for NAVIGATE I: Randomized, Placebo-Controlled, Double-Blind Trial of the Exhalation Delivery System With Fluticasone for Chronic Rhinosinusitis With Nasal Polyps

Author

Sindwani, Raj, Han, Joseph K., Soteres, Daniel F., Messina, John C., Carothers, Jennifer L., Mahmoud, Ramy A., and Djupesland, Per G.

Subjects
110315 Otorhinolaryngology, FOS: Clinical medicine
Abstract

Supplemental Material for NAVIGATE I: Randomized, Placebo-Controlled, Double-Blind Trial of the Exhalation Delivery System With Fluticasone for Chronic Rhinosinusitis With Nasal Polyps by Raj Sindwani, Joseph K. Han, Daniel F.Soteres, John C.Messina, Jennifer L.Carothers, Ramy A.Mahmoud, Per G.Djupesland in American Journal of Rhinology & Allergy

Published
2018
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28. NAVIGATE I: Randomized, Placebo-Controlled, Double-Blind Trial of the Exhalation Delivery System With Fluticasone for Chronic Rhinosinusitis With Nasal Polyps.

Author

Sindwani, Raj, Han, Joseph K., Soteres, Daniel F., Messina, John C., Carothers, Jennifer L., Mahmoud, Ramy A., and Djupesland, Per G.

Subjects
NASAL polyps, FACIAL pain, NASAL irrigation, SINUSITIS, FLUTICASONE, THERAPEUTICS, SLEEP
Abstract

Background Chronic rhinosinusitis is a common, high-morbidity chronic inflammatory disease, and patients often experience suboptimal outcomes with current medical treatment. The exhalation delivery system with fluticasone (EDS-FLU) may improve care by increasing superior/posterior intranasal corticosteroid deposition. Objective To evaluate the efficacy and safety of EDS-FLU versus EDS-placebo in patients with nasal polyps (NP). Coprimary end points were change in nasal congestion and polyp grade. Key secondary end points were Sino-Nasal Outcome Test-22 (SNOT-22) and Medical Outcomes Study Sleep Scale-Revised (MOS Sleep-R). Other prespecified end points included all 4 cardinal symptoms of NP, 36-Item Short Form Health Survey (SF-36), Patient Global Impression of Change (PGIC), Rhinosinusitis Disability Index (RSDI), and key indicators for surgical intervention. Design Randomized, double-blind, EDS-placebo-controlled, multicenter study. Methods Three hundred twenty-three subjects with NP and moderate-severe congestion/obstruction, most with history of corticosteroid use (94.4%) and/or prior surgery (60.4%), were randomized to EDS-FLU 93 µg, 186 µg, or 372 µg or EDS-placebo twice daily (BID) for 24 weeks (16 double-blind + 8 single-arm extension with EDS-FLU 372 µg BID). Results All EDS-FLU doses produced significant improvement in both coprimary end points (P < .05) and in SNOT-22 total score (P ≤ .005). EDS-FLU significantly improved all 4 cardinal symptoms of NP (P < .05), including congestion/obstruction, facial pain/pressure, rhinorrhea/post-nasal drip, and hyposmia/anosmia. Approximately 80% of subjects reported improvement with EDS-FLU, with 65% reporting "much" or "very much" improvement by week 16. Adverse events were generally local in nature and similar to other intranasal steroids studied for similar durations in similar populations, with the most common being epistaxis. Conclusions In patients with chronic rhinosinusitis with NP (CRSwNP) who were symptomatic despite high rates of prior intranasal steroid use and/or surgery, EDS-FLU produced statistically significant and clinically meaningful improvements compared to EDS-placebo in multiple subjective and objective outcomes (symptoms, SNOT-22, RSDI, SF-36, PGIC, and NP grade), including all 4 cardinal symptoms of CRSwNP. [ABSTRACT FROM AUTHOR]

Published
2019
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