Background

Although it is known that oral antihistamine-pseudoephedrine combination tablets have a faster onset than intranasal corticosteroid sprays in the treatment of allergic rhinitis after the first dose, the magnitude of change has not been measured in a comparative manner. Furthermore, the sensation of sprayed liquid in the nose may lead patients to mistakenly believe that intranasal steroid sprays work instantly.

Objective

To evaluate, numerically, nasal airflow changes provided by a single dose of loratadine-pseudoephedrine tablet (LP) and fluticasone propionate nasal spray (FP) in participants experiencing allergic rhinitis symptoms, including nasal congestion.

Methods

This single-center, double-blinded, placebo-controlled, crossover study evaluated objective nasal airflow changes in patients with a documented sensitivity to ragweed pollen. Participants were randomized to receive 1 of 4 treatment sequences, and their peak nasal inspiratory flow (PNIF) was measured in a span of 4 hours after pollen exposure in an environmental exposure unit.

Results

Average change in PNIF was 31% with LP in the course of the study, significantly greater than with placebo and FP (12% and 15%, respectively; P < .001). Nevertheless, FP did not produce a significant change compared with its placebo. At hour one post-dose, LP had a clinically significant 31% increase in PNIF, whereas FP only yielded an 8.6% increase (P < .001). Measurable nasal airflow improvements are associated with the opening of nasal passages, allowing congested patients to breathe more freely.

Conclusion

A single dose of LP quickly and significantly (P < .001) improved nasal airflow after ragweed pollen challenge in an environmental exposure unit. Comparatively, FP did not display this same benefit.

Trial Registration

ClinicalTrials.gov Identifier: NCT03443843.

中文翻译：

---

氯雷他定-伪麻黄碱和氟替卡松喷鼻剂治疗过敏性鼻炎的鼻气流比较

背景

尽管已知口服抗组胺药-伪麻黄碱复方片剂在首次给药后治疗过敏性鼻炎时比鼻内皮质类固醇喷雾剂起效更快，但尚未以比较方式测量变化幅度。此外，鼻内喷洒液体的感觉可能会导致患者错误地认为鼻内类固醇喷雾剂立即起作用。

客观的

以数值方式评估单剂量氯雷他定-伪麻黄碱片 (LP) 和丙酸氟替卡松喷鼻剂 (FP) 对出现过敏性鼻炎症状（包括鼻塞）的参与者的鼻腔气流变化。

方法

这项单中心、双盲、安慰剂对照、交叉研究评估了对豚草花粉敏感的患者的客观鼻气流变化。参与者随机接受 4 个治疗序列中的 1 个，并在花粉暴露于环境暴露单元后的 4 小时内测量他们的峰值鼻吸气流量 (PNIF)。

结果

在研究过程中，LP 的 PNIF 平均变化为 31%，显着高于安慰剂和 FP（分别为 12% 和 15%；P < .001）。尽管如此，与安慰剂相比，FP 并没有产生显着的变化。在给药后一小时，LP 的 PNIF 临床显着增加了 31%，而 FP 仅增加了 8.6% ( P < .001)。可测量的鼻腔气流改善与鼻腔通道的开放有关，使拥挤的患者可以更自由地呼吸。

结论

 在环境暴露单元中，豚草花粉攻击后，单剂量的 LP 快速且显着 ( P < .001) 改善了鼻腔气流。相比之下，FP 没有表现出同样的好处。

试用注册

ClinicalTrials.gov 标识符：NCT03443843。