Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: Results from two randomised controlled trials

Respiratory Medicine
James F DonohueAlison Church

Abstract

Dual therapy with bronchodilators of different pharmacological classes may produce greater lung function improvements than either drug alone. However, the relationship between a patient's response to monotherapy and response to dual bronchodilator therapy is currently unknown. We aimed to investigate whether dual therapy with umeclidinium/vilanterol provides additional benefit over umeclidinium or vilanterol monotherapy in patients with chronic obstructive pulmonary disease (COPD) identified as responsive (increase from baseline in forced expiratory volume in 1s [FEV1] of ≥ 12% and ≥ 200 mL, Day 1) or non-responsive to monotherapy. In two randomised, double-blind, three-way complete-block, cross-over studies (DB2116132 n = 207; DB2116133 n = 182; intent-to-treat), all patients (moderate-to-very severe COPD) were randomised to 1 of 6 sequences and received once-daily umeclidinium 62.5 mcg, vilanterol 25 mcg, and umeclidinium/vilanterol 62.5/25 mcg (one treatment/14-day period; 10-14-day washout). Key endpoints were 0-6 h weighted mean FEV1 (Day 14) and trough FEV1 (Day 15). Adverse events, vital signs and COPD exacerbations were assessed. Pooled data are presented. Umeclidinium/vilanterol significantly (p ≤ 0.001, unless stated ...Continue Reading

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Citations

May 5, 2016·Expert Review of Respiratory Medicine·Mario MalerbaJaymin B Morjaria
Apr 12, 2017·Postgraduate Medicine·Nicola A HananiaBarbara P Yawn
Dec 7, 2016·American Journal of Respiratory and Critical Care Medicine·Kai M BeehJadwiga A Wedzicha
Feb 17, 2018·Expert Review of Respiratory Medicine·Luigino CalzettaMario Cazzola
Mar 21, 2018·COPD·Jose Luis Lopez-Campos, Stefano Centanni
Jun 21, 2017·The Cochrane Database of Systematic Reviews·Han NiSoe Moe
May 3, 2018·Expert Opinion on Drug Safety·Paola RoglianiLuigino Calzetta
Jun 21, 2018·Respirology : Official Journal of the Asian Pacific Society of Respirology·Jose Luis Lopez-CamposEsther Barreiro
Sep 27, 2019·Respirology : Official Journal of the Asian Pacific Society of Respirology·Dave Singh
Nov 7, 2019·Therapeutic Advances in Respiratory Disease·Jose Luis Lopez-CamposJoan B Soriano
Aug 29, 2020·Journal of Clinical Medicine·José Luis Lopez-CamposCandelaria Caballero-Eraso
Dec 29, 2020·Journal of Experimental Pharmacology·Robert M Burkes, Ralph J Panos
Apr 9, 2021·Respirology : Official Journal of the Asian Pacific Society of Respirology·Dave Singh
Apr 13, 2021·Archivos de bronconeumología·Marc MiravitllesJuan José Soler-Cataluña
May 1, 2021·Journal of Clinical Medicine·Laura Carrasco HernándezJose Luis Lopez-Campos
Jul 22, 2021·International Journal of Chronic Obstructive Pulmonary Disease·Jose Luis López-CamposCandelaria Caballero-Eraso

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