Berger William, Sher Ellen, Gawchik Sandra, Fineman Stanley
From the Allergy and Asthma Associates of Southern California, Mission Viejo, California, USA.
Atlantic Allergy, Asthma and Immunology Associates of New Jersey, Ocean, New Jersey, USA.
Allergy Asthma Proc. 2018 Mar 1;39(2):110-116. doi: 10.2500/aap.2018.39.4116.
The safety of a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) has been established in adults and adolescents with allergic rhinitis but not in children <12 years old.
To evaluate the safety and tolerability of an intranasal formulation of AZE and FP in children ages 4-11 years with allergic rhinitis.
The study was a randomized, 3-month, parallel-group, open-label design. Qualified patients were randomized in a 3:1 ratio to AZE/FP (n = 304) or fluticasone propionate (FP) (n = 101), one spray per nostril twice daily, and to one of three age groups: ≥4 to <6 years, ≥6 to <9 years, and ≥9 to <12 years. Safety was assessed by child- or caregiver-reported adverse events, nasal examinations, vital signs, and laboratory assessments.
The incidence of treatment-related adverse events (TRAEs) was low in both the AZE/FP (16%) and FP-only (12%) groups after 90 days' continuous use. Epistaxis was the most frequently reported TRAE in both groups (AZE/FP, 9%; FP, 9%), followed by headache (AZE/FP, 3%; FP, 1%). All other TRAEs in the AZE/FP group were reported by ≤1% of the children. The majority of TRAEs were of mild intensity and resolved spontaneously. Results of nasal examinations showed an improvement over time in both groups, with no cases of mucosal ulceration or nasal septal perforation. There were no unusual or unexpected changes in laboratory parameters or vital signs.
The intranasal formulation of AZE and FP was safe and well tolerated after 3 months' continuous use in children with allergic rhinitis.The study was registered on
盐酸氮卓斯汀（AZE）和丙酸氟替卡松（FP）的新型鼻内制剂在患有过敏性鼻炎的成人和青少年中的安全性已得到证实，但在12岁以下儿童中尚未得到证实。
评估AZE和FP鼻内制剂在4至11岁过敏性鼻炎儿童中的安全性和耐受性。
该研究为随机、为期3个月的平行组开放标签设计。符合条件的患者按3:1的比例随机分为AZE/FP组（n = 304）或丙酸氟替卡松（FP）组（n = 101），每天每侧鼻孔喷两次，分为三个年龄组之一：≥4至<6岁、≥6至<9岁和≥9至<12岁。通过儿童或照顾者报告的不良事件、鼻检查、生命体征和实验室评估来评估安全性。
连续使用90天后，AZE/FP组（16%）和仅使用FP组（12%）的治疗相关不良事件（TRAE）发生率均较低。鼻出血是两组中最常报告的TRAE（AZE/FP组为9%；FP组为9%），其次是头痛（AZE/FP组为3%；FP组为1%）。AZE/FP组中所有其他TRAE的报告率均≤1%的儿童。大多数TRAE为轻度，可自行缓解。鼻检查结果显示两组随时间均有改善，无黏膜溃疡或鼻中隔穿孔病例。实验室参数或生命体征无异常或意外变化。
AZE和FP的鼻内制剂在过敏性鼻炎儿童中连续使用3个月后安全且耐受性良好。该研究已在
