Tagaya Etsuko, Shinada Jun, Nagase Hiroyuki, Terada-Hirashima Junko, Hojo Masayuki, Sugihara Naruhiko, Yagi Osamitsu, Tsuji Mayoko, Akaba Tomohiro, Masaki Katsunori, Fukunaga Koichi, Ohbayashi Hiroyuki, Chiba Kaoru, Hozawa Soichiro, Atsuta Ryo, Aoki Yasuhiro, Hiranuma Hisato, Gon Yasuhiro, Tanaka Akihiko
Department of Respiratory Medicine, Tokyo Women's Medical University, Tokyo, Japan.
Shinada Respiratory and Cardiovascular Clinic, Kanagawa, Japan.
J Asthma. 2025 Jun;62(6):1041-1051. doi: 10.1080/02770903.2025.2455416. Epub 2025 Feb 3.
Persistent cough bothers many patients with asthma because it worsens their quality of life; therefore, it must be remedied immediately. The efficacy of triple therapy as a first-line treatment for cough remains unclear. To evaluate the effectiveness and safety of the triple therapy against persistent cough, the clinical effect of regular treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or placebo in adult patients with asthma was investigated.
This randomized, double-blind, placebo-controlled, parallel-group multicenter trial recruited asthma patients with persistent cough from hospitals and primary care clinics between June 2022 and December 2023. Participants were randomly given FF/UMEC/VI 200/62.5/25 µg or placebo for 6 wk. The primary endpoint was the average change in the cough symptom score from baseline to week 6. Secondary outcomes were effectiveness on cough-related disease burdens (asthma control questionnaire [ACQ]-5, Leicester cough questionnaire [LCQ] and nighttime awakening). Furthermore, lung function and adverse events were evaluated.
The decrease from baseline in the cough symptom score at week 6 was significantly greater in the FF/UMEC/VI group than in the placebo group ( = 0.006). The ACQ-5 scores showed a greater decrease in the FF/UMEC/VI group than in the placebo group. The change from baseline in morning and evening FEV increased in the FF/UMEC/VI group as with the results of peak expiratory flow. No significant adverse events associated with FF/UMEC/VI were noted.
In asthma patients with persistent cough, FF/UMEC/VI showed an early response and a significant effect on cough and lung function for 6 wk of treatment.
This study is registered with jRCTs031210412.
持续性咳嗽困扰着许多哮喘患者，因为它会降低他们的生活质量；因此，必须立即加以治疗。三联疗法作为咳嗽一线治疗方法的疗效仍不明确。为了评估三联疗法治疗持续性咳嗽的有效性和安全性，我们调查了糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）或安慰剂常规治疗对成年哮喘患者的临床效果。
这项随机、双盲、安慰剂对照、平行组多中心试验于2022年6月至2023年12月期间从医院和基层医疗诊所招募患有持续性咳嗽的哮喘患者。参与者被随机给予200/62.5/25µg的FF/UMEC/VI或安慰剂，为期6周。主要终点是从基线到第6周咳嗽症状评分的平均变化。次要结果是对咳嗽相关疾病负担（哮喘控制问卷[ACQ]-5、莱斯特咳嗽问卷[LCQ]和夜间觉醒）的有效性。此外，还评估了肺功能和不良事件。
FF/UMEC/VI组在第6周时咳嗽症状评分较基线的下降幅度显著大于安慰剂组（P = 0.006）。ACQ-5评分在FF/UMEC/VI组中的下降幅度大于安慰剂组。与呼气峰值流速结果一样，FF/UMEC/VI组早晚FEV较基线的变化有所增加。未发现与FF/UMEC/VI相关的显著不良事件。
在患有持续性咳嗽的哮喘患者中，FF/UMEC/VI在治疗6周时对咳嗽和肺功能显示出早期反应和显著效果。
本研究已在jRCTs031210412注册。
