Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry & Biomedical Science, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, Northern Ireland.
Sher Allergy Specialists, LLC, Largo, FL, USA.
Lung. 2023 Apr;201(2):111-118. doi: 10.1007/s00408-023-00606-w. Epub 2023 Mar 6.
We evaluated gefapixant, a P2X3 receptor antagonist, in participants with recent-onset (≤ 12 months) refractory chronic cough (RCC) or unexplained chronic cough (UCC).
Participants (≥ 18 years of age; ≥ 40 mm on a 100-mm cough severity visual analog scale [VAS] at screening and randomization) with chronic cough for < 12 months were enrolled in this phase 3b, double-blind, placebo-controlled, parallel group, multicenter study (NCT04193202). Participants were randomized 1:1 to gefapixant 45 mg BID or placebo for 12 weeks with a 2-week follow-up. The primary efficacy endpoint was change from baseline at Week 12 in Leicester Cough Questionnaire (LCQ) total score. Adverse events were monitored and evaluated.
There were 415 participants randomized and treated (mean age 52.5 years; median [range] duration 7.5 [1-12] months): 209 received placebo and 206 received gefapixant 45 mg BID. A statistically significant treatment difference of 0.75 (95% CI: 0.06, 1.44; p = 0.034) for gefapixant vs. placebo was observed for change from baseline in LCQ total score at Week 12. The most common AE was dysgeusia (32% gefapixant vs. 3% placebo participants); serious AEs were rare (1.5% gefapixant vs. 1.9% placebo participants).
Gefapixant 45 mg BID demonstrated significantly greater improvement in cough-specific health status from baseline compared to placebo, in participants with recent-onset chronic cough. The most common AEs were related to taste and serious AEs were rare.
我们评估了 P2X3 受体拮抗剂 gefapixant 在近期发作（≤12 个月）难治性慢性咳嗽（RCC）或不明原因慢性咳嗽（UCC）患者中的疗效。
本 3b 期、双盲、安慰剂对照、平行分组、多中心研究（NCT04193202）入组了年龄≥18 岁（筛选和随机分组时咳嗽严重程度视觉模拟量表[VAS]≥100mm 为≥40mm）、慢性咳嗽时间＜12 个月的患者。患者按 1:1 随机分组，分别接受 gefapixant 45mg，每日 2 次（BID）或安慰剂治疗 12 周，随后进行 2 周随访。主要疗效终点为第 12 周时与基线相比莱斯特咳嗽问卷（LCQ）总分的变化。监测和评估不良事件。
共有 415 名患者随机分组并接受治疗（平均年龄 52.5 岁；中位数[范围]病程 7.5[1-12]个月）：209 名患者接受安慰剂治疗，206 名患者接受 gefapixant 45mg BID 治疗。与安慰剂相比，第 12 周时 LCQ 总分的变化 gefapixant 治疗组有统计学显著的 0.75（95%CI：0.06，1.44；p=0.034）改善。最常见的不良事件是味觉障碍（32% gefapixant 与 3%安慰剂患者）；严重不良事件罕见（1.5% gefapixant 与 1.9%安慰剂患者）。
与安慰剂相比，Gefapixant 45mg BID 可显著改善近期发作慢性咳嗽患者的咳嗽特异性健康状况。最常见的不良事件与味觉有关，严重不良事件罕见。
