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

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.

     

人鼻息肉及鼻息肉病组织中GM—CSF、IL-5的表达变化及临床意义

目的探讨粒细胞巨噬细胞集落刺激因子（GM-CSF）和IL-5在人鼻息肉及鼻息肉病组织中表达变化及临床价值。方法采用免疫组化SP法检测30例鼻息肉组织（息肉组）、23例鼻息肉病组织（息肉病组）及15例正常鼻黏膜（对照组）中GM-CSF及IL-5的表达状况。结果息肉病组的GM—CSF及IL-5表达量均明显高于息肉组、息肉组明显高于对照组（P均〈0．05）。结论鼻息肉病高复发性与GM-CSF及IL-5的高表达水平有关;GM—CSF及IL-5可以作为鉴别鼻息肉病和鼻息肉的组织学参考指标之一。