MACVIA-France, Contre les MAladies Chroniques pour un VIeillissement Actif en France European Innovation Partnership on Active and Healthy Ageing Reference Site, Montpellier, France; INSERM U 1168, VIMA: Ageing and chronic diseases Epidemiological and public health approaches, Villejuif, Université Versailles St-Quentin-en-Yvelines; Euforea, Brussels, Belgium; Charité, Berlin, Germany.
Allergy and Asthma Medical Group and Research Center, San Diego, Calif.
J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1726-1732.e6. doi: 10.1016/j.jaip.2018.01.031. Epub 2018 Feb 7.
A fixed-dose combination of intranasal azelastine hydrochloride and fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis, but its onset of action requires further investigation.
To compare the onset of action of MP-AzeFlu with the free combination of oral loratadine (LORA) and intranasal fluticasone propionate (INFP).
In this single-center, randomized, placebo-controlled, double-blind, double-dummy, 3-period crossover trial, allergic rhinitis symptoms were induced in asymptomatic patients by ragweed pollen challenge in an allergen environmental exposure chamber. Patients received single-dose MP-AzeFlu, LORA/INFP, or placebo and were monitored for 4 hours. The primary outcome was onset of action measured by total nasal symptom score (TNSS). Secondary measures were total ocular symptom score (TOSS), total score of the 7 nasal and ocular symptoms (T7SS), and the global visual analog scale (VAS).
The full analysis set included 82 patients, of which 78 completed all treatments. TNSS was significantly reduced versus placebo from 5 minutes for MP-AzeFlu and 150 minutes for LORA/INFP onward (both P < .05) till the end of assessment (0-4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P < .05) and over the entire assessment interval (P ≤ .005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P = .182). The onset of action of MP-AzeFlu assessed by TOSS, T7SS, and VAS was 10 minutes, 2 hours earlier than with LORA/INFP.
MP-AzeFlu had a more rapid onset of action (5 minutes) and was more effective than LORA/INFP.
盐酸氮卓斯汀和丙酸氟替卡松的固定剂量组合（MP-AzeFlu）是治疗过敏性鼻炎最有效的药物，但它的作用起效时间仍需要进一步研究。
比较 MP-AzeFlu 与口服氯雷他定（LORA）和鼻内丙酸氟替卡松（INFP）的自由组合的作用起效时间。
在这项单中心、随机、安慰剂对照、双盲、双模拟、3 期交叉试验中，在变应原环境暴露室内，通过豚草花粉挑战使无症状患者出现变应性鼻炎症状。患者接受单剂量 MP-AzeFlu、LORA/INFP 或安慰剂治疗，并监测 4 小时。主要结局指标为总鼻症状评分（TNSS）的作用起效时间。次要指标包括总眼部症状评分（TOSS）、7 个鼻部和眼部症状总评分（T7SS）以及整体视觉模拟评分（VAS）。
全分析集纳入 82 例患者，其中 78 例完成了所有治疗。与安慰剂相比，MP-AzeFlu 从 5 分钟起，LORA/INFP 从 150 分钟起，TNSS 显著降低（均 P<.05），直至评估结束（0-4 小时）。MP-AzeFlu 在 5 至 90 分钟的每个时间点均较 LORA/INFP 或安慰剂更显著地降低 TNSS（P<.05），且在整个评估间隔内（P≤.005）也是如此。在评估间隔内，LORA/INFP 与安慰剂之间无统计学差异（P=.182）。通过 TOSS、T7SS 和 VAS 评估的 MP-AzeFlu 作用起效时间为 10 分钟，早于 LORA/INFP 的 2 小时。
MP-AzeFlu 的作用起效时间更快（5 分钟），且比 LORA/INFP 更有效。
