TY - JOUR T1 - Real-life effectiveness of indacaterol/glycopyrronium/mometasone for symptomatic relief of cough after switching from ICS/LABA therapy in patients with asthma: REACH study design JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00452-2022 SP - 00452-2022 AU - Akio Niimi AU - Yoshihiro Kanemitsu AU - Tomoko Tajiri AU - Kazuya Sumi AU - Toshiaki Mikami AU - Norihiko Kondo Y1 - 2022/01/01 UR - http://openres.ersjournals.com/content/early/2022/12/14/23120541.00452-2022.abstract N2 - Cough is a major symptom in patients with asthma and poses a significant burden compared to other asthma symptoms. However, there are no approved treatments in Japan, developed to specifically treat cough in patients with asthma. We present the design of REACH, an 8-week real-life study, which will evaluate the efficacy of a combination of indacaterol acetate, glycopyrronium bromide, and mometasone furoate (IND/GLY/MF) in asthmatic patients with cough refractory to medium-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA).Patients with asthma (≥20 to <80 years) with a cough visual analogue scale (VAS) ≥40 mm will be randomised 2:1:1 to receive IND/GLY/MF medium-dose 150/50/80 μg o.d. or step up to high-dose regimen of fluticasone furoate/vilanterol trifenatate (FF/VI) 200/25 µg o.d. or budesonide/formoterol fumarate (BUD/FM) 160/4.5 µg, 4 inhalations b.i.d. during the 8-week treatment period. The primary objective is to demonstrate superiority of IND/GLY/MF medium-dose over high-dose ICS/LABA in terms of cough-specific quality of life after 8 weeks. The key secondary objective is to demonstrate the superiority of IND/GLY/MF in terms of subjective assessment of cough severity.Cough frequency (VitaloJAK cough monitor) and capsaicin cough receptor sensitivity will be evaluated in eligible patients. Cough VAS scores, FeNO, spirometry and blood tests, Asthma Control Questionnaire-6, Cough and Sputum Assessment Questionnaire, and Japanese version of Leicester Cough Questionnaire will be evaluated.REACH will provide valuable evidence on whether a switch to IND/GLY/MF medium dose or step up to high-dose ICS/LABA is beneficial for patients with persistent cough despite treatment with medium-dose ICS/LABA.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: A Niimi reports grant from KYORIN Pharmaceutical Co., Ltd., payment or honoraria for speaker's fee from AstraZeneca K.K., KYORIN Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., Sanofi K.K., and Novartis Pharma K.K., and participation on a Data Safety Monitoring Board or Advisory Board of KYORIN Pharmaceutical Co., Ltd., and MSD K.K.Conflict of interest: Y Kanemitsu reports grant from MSD K.K., Sanofi K.K., and Novartis Pharma K.K., payment or honoraria for speaker's fee from AstraZeneca K.K., KYORIN Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., Sanofi K.K., and Novartis Pharma K.K.Conflict of interest: T Tajiri reports payment or honoraria for speaker's fee from AstraZeneca K.K., GlaxoSmithKline K.K., Sanofi K.K., and Novartis Pharma K.K..Conflict of interest: K Sumi, T Mikami and N Kondo are employees of Novartis Pharma K.K, Japan. ER -