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.

International Journal of Chronic Obstructive Pulmonary Disease
Donald P TashkinHeribert Staudinger

Abstract

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). Two 52-week, multicenter, double-blind, placebo-controlled trials with identical study designs were conducted in current or ex-smokers (aged ≥40 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 μg, MF/F 200/10 μg, MF 400 μg, F 10 μg, 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 (FEV(1)), area under the curve from 0 to 12 hours postdose (AUC(0-12 h)), and morning predose/trough FEV(1) 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. In the 26-week treatment period, significantly greater increases in FEV(1) A...Continue Reading

References

Jun 1, 1992·The American Review of Respiratory Disease·P W JonesP Littlejohns
Apr 20, 1999·Chest·D A MahlerW H Anderson
Feb 13, 2001·Pulmonary Pharmacology & Therapeutics·M CazzolaP Santus
Sep 11, 2001·American Journal of Respiratory and Critical Care Medicine·R DahlUNKNOWN Formoterol in Chronic Obstructive Pulmonary Disease I Study Group
Feb 28, 2002·The European Respiratory Journal·R CasaburiT Witek
Feb 14, 2003·Lancet·Peter CalverleyUNKNOWN TRial of Inhaled STeroids ANd long-acting beta2 agonists study group
Jun 29, 2004·The European Respiratory Journal·B R CelliUNKNOWN ATS/ERS Task Force
Aug 2, 2005·The European Respiratory Journal·M R MillerUNKNOWN ATS/ERS Task Force
Feb 23, 2007·The New England Journal of Medicine·Peter M A CalverleyUNKNOWN TORCH investigators
May 18, 2007·American Journal of Respiratory and Critical Care Medicine·Klaus F RabeUNKNOWN Global Initiative for Chronic Obstructive Lung Disease
May 31, 2008·American Journal of Respiratory and Critical Care Medicine·Bartolomé R CelliPeter M A Calverley
Oct 7, 2008·The New England Journal of Medicine·Donald P TashkinUNKNOWN UPLIFT Study Investigators
Nov 19, 2008·Respiratory Research·Peter M A CalverleyHeribert Staudinger
Nov 27, 2008·JAMA : the Journal of the American Medical Association·M Bradley DrummondEddy Fan
Oct 23, 2010·Respiratory Medicine·P M A CalverleyV Brusasco
Jun 2, 2011·Respiratory Research·Paul W JonesUNKNOWN TORCH investigators

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Citations

Apr 13, 2013·Drugs & Aging·Timothy E AlbertsonAndrew L Chan
Apr 22, 2014·International Journal of Chronic Obstructive Pulmonary Disease·Brian Mieczkowski, Michael E Ezzie
Aug 5, 2014·Current Respiratory Care Reports·Daan A De Coster, Melvyn Jones
Feb 19, 2014·Respiratory Medicine·Kai-Michael BeehDonald Banerji

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Methods Mentioned

BETA
nuclear translocation

Clinical Trials Mentioned

NCT00383435
NCT00383721

Software Mentioned

SAS
GENMOD
MasterScope

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