Efficacy and safety of a fixed-dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52-week Phase III trial.

International Journal of Chronic Obstructive Pulmonary Disease
Donald P TashkinHeribert Staudinger

Abstract

A clinical trial of mometasone furoate/formoterol fumarate (MF/F) administered via a metered-dose inhaler in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD) investigated the efficacy and safety of a fixed-dose combination of MF/F. This multicenter, double-blind, placebo-controlled trial had a 26-week treatment period and a 26-week safety extension. Subjects (n = 1055; ≥40 years) were current or ex- smokers randomized to twice-daily treatment with inhaled MF/F 400/10 μg, MF/F 200/10 μg, MF 400 μg, F 10 μg, or placebo. The coprimary endpoints of the trial were mean changes from baseline in forced expiratory volume in 1 second (FEV(1)) over 0-12 hours (AUC(0-12) FEV(1)) with MF/F versus MF, and in morning predose FEV(1) with MF/F versus F. Key secondary endpoints were quality of life (Saint George's Respiratory Questionnaire [SGRQ]), symptom-free nights, and partly stable COPD at 26 weeks, as well as time to first COPD exacerbation. Significant improvements in FEV(1) AUC(0-12) occurred at endpoint with MF/F 400/10 and MF/F 200/10 versus MF 400 (P ≤ 0.007). Significant bronchodilation occurred in 5 minutes with MF/F, and serial spirometry demonstrated sustained FEV(1) improvements with MF/F over t...Continue Reading

References

Jun 1, 1992·The American Review of Respiratory Disease·P W JonesP Littlejohns
Feb 13, 2001·Pulmonary Pharmacology & Therapeutics·M CazzolaP Santus
Nov 6, 2003·JAMA : the Journal of the American Medical Association·S F Paul ManDon D Sin
Nov 26, 2004·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Andrea S MelaniUNKNOWN Associazione Italiana Pneumologi Ospedalieri Educational Group
May 17, 2006·Primary Care Respiratory Journal : Journal of the General Practice Airways Group·Sonia Buist
Dec 1, 2007·International Journal of Chronic Obstructive Pulmonary Disease·Erkan Ceylan
Oct 31, 2008·COPD·Dennis E Doherty
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
Sep 17, 2010·The New England Journal of Medicine·John R HurstUNKNOWN Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators
Sep 30, 2010·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·Jorge F MasperoUNKNOWN P04139 Study Group
May 3, 2011·Respiratory Medicine·Bartolome R CelliUbaldo J Martin
Aug 11, 2011·The European Respiratory Journal·E O MeltzerUNKNOWN P04073 Study Investigators

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Citations

Feb 5, 2013·International Journal of Chronic Obstructive Pulmonary Disease·Marc L DecramerBarbara P Yawn
Nov 29, 2013·Drug Design, Development and Therapy·Annette J TheronRonald Anderson
Nov 12, 2013·The Cochrane Database of Systematic Reviews·Luis Javier NanniniRebecca Normansell

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Methods Mentioned

BETA
pharmacotherapy

Clinical Trials Mentioned

NCT00383435

Software Mentioned

SAS
CCBR
Synarc

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