マツモト　エツコ   MATSUMOTO Etsuko   松本　悦子    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	The efficacy and safety of Fluticasone Furoate/Umeclidinium/vilanterol (FF/UMEC/VI) on cough symptoms in adult patients with asthma, a randomized double-blind, placebo-controlled, parallel group study: Chronic Cough in Asthma (COCOA) study.
掲載誌名	正式名：The Journal of asthma : official journal of the Association for the Care of Asthma 略　 称：J Asthma ISSNコード：15324303/02770903
掲載区分	国外
巻・号・頁	pp.1-11
著者・共著者	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
担当区分	筆頭著者
発行年月	2025/02
概要	BACKGROUND: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.METHODS: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.RESULTS: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 (p = 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 FEV1 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.CONCLUSIONS: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.UNLABELLED:This study is registered with jRCTs031210412.
DOI	10.1080/02770903.2025.2455416
PMID	39874464