%0 Journal Article
%T Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials
%A Tashkin DP
%A Doherty DE
%A Kerwin E
%A Matiz-Bueno CE
%A Knorr B
%A Shekar T
%A Gates D
%A Staudinger H
%J International Journal of Chronic Obstructive Pulmonary Disease
%D 2012
%I 
%R http://dx.doi.org/10.2147/COPD.S29444
%X acy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials Original Research (4096) Total Article Views Authors: Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, Gates D, Staudinger H Published Date February 2012 Volume 2012:7 Pages 73 - 86 DOI: http://dx.doi.org/10.2147/COPD.S29444 Received: 24 December 2011 Accepted: 19 January 2012 Published: 03 February 2012 Donald P Tashkin1, Dennis E Doherty2, Edward Kerwin3, Carlos E Matiz-Bueno4, Barbara Knorr5, Tulin Shekar5, Davis Gates5, Heribert Staudinger5 1David Geffen School of Medicine at UCLA, Los Angeles, CA, 2Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KY, 3Clinical Research Institute of Southern Oregon, Medford, OR, USA; 4Fundaci¨®n Salud Bosque, Bogota, Colombia, 5Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA Background: The clinical efficacy and safety of a mometasone furoate/formoterol fumarate (MF/F) fixed-dose combination formulation administered via a metered-dose inhaler was investigated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Methods: Two 52-week, multicenter, double-blind, placebo-controlled trials with identical study designs were conducted in current or ex-smokers (aged ¡Ý40 years), and pooled study results are presented herein. Subjects (n = 2251) were randomized to 26 weeks of twice-daily treatment with MF/F 400/10 ¦Ìg, MF/F 200/10 ¦Ìg, MF 400 ¦Ìg, F 10 ¦Ìg, or placebo. After the 26-week treatment period, placebo subjects completed the trial and 75% of subjects on active treatment entered a 26-week safety extension. Coprimary efficacy variables were mean changes in forced expiratory volume in one second (FEV1), area under the curve from 0 to 12 hours postdose (AUC0¨C12 h), and morning predose/trough FEV1 from baseline to the week 13 endpoint. Key secondary efficacy variables were St George¡¯s Respiratory Questionnaire scores, symptom-free nights, time-to-first exacerbation, and partly stable COPD at the week 26 endpoint. Results: In the 26-week treatment period, significantly greater increases in FEV1 AUC0¨C12 h occurred with MF/F 400/10 versus MF 400 and placebo at the week 13 and week 26 endpoints (P ¡Ü 0.032). These increases were over three-fold greater with MF/F 400/10 than with MF 400. Also, significantly greater increases in morning predose/trough FEV1 occurred with MF/F 400/10 versus F 10 and placebo at the week 13 endpoint (P < 0.05). The increase was four-fold greater with MF/F 400/10 than with F 10. All active treatment groups achieved minimum clinically important differences from baseline (>4 units) in St George¡¯s Respiratory Questionnaire scores at week 26. Symptom-free nights increased by ¡Ý14% in the MF/F 400/10, MF 400, and F 10 groups (P ¡Ü 0.033 versus placebo). The incidence of exacerbati
%K COPD
%K spirometry
%K exacerbation
%K inhaled corticosteroid
%K bronchodilator
%U https://www.dovepress.com/efficacy-and-safety-characteristics-of-mometasone-furoateformoterol-fu-peer-reviewed-article-COPD