PMID- 22334769
OWN - NLM
STAT- MEDLINE
DCOM- 20120531
LR  - 20211021
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 7
DP  - 2012
TI  - Effects of mometasone furoate/formoterol fumarate fixed-dose combination 
      formulation on chronic obstructive pulmonary disease (COPD): results from a 
      52-week Phase III trial in subjects with moderate-to-very severe COPD.
PG  - 57-71
LID - 10.2147/COPD.S27320 [doi]
AB  - RATIONALE: The purpose of this study was to investigate the clinical efficacy and 
      safety of a fixed-dose combination 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). METHODS: This multicenter, 
      double-blind, placebo-controlled trial had a 26-week treatment period and a 
      26-week safety extension. Subjects (n = 1196), at least 40 years old, were 
      current or ex-smokers randomized to twice-daily inhaled MF/F 400/10 mug, MF/F 
      200/10 mug, MF 400 mug, F 10 mug, or placebo. The trial's co-primary endpoints were 
      mean changes from baseline, as area under the curve (AUC), in forced expiratory 
      volume (FEV(1)) over 0-12 hours (AUC(0-12 h) FEV(1)) with MF/F versus MF, and in 
      morning (AM) pre-dose (trough) FEV(1) with MF/F versus F after 13 weeks of 
      treatment. Key secondary endpoints were the effects of MF/F on respiratory health 
      status using the Saint George's Respiratory Questionnaire (SGRQ), symptom-free 
      nights, partly stable COPD at 26 weeks, and time to first COPD exacerbation. 
      RESULTS: The largest improvements in AUC(0-12 h) FEV(1) were observed with MF/F 
      400/10 mug and MF/F 200/10 mug. Serial spirometry results demonstrated that 
      bronchodilator effects with MF/F occurred rapidly (within 5 minutes), persisted 
      for 12 hours after dosing, and were sustained over the 26-week treatment period. 
      Similar findings were observed for AM pre-dose FEV(1), for which effects were 
      further investigated, excluding subjects whose AM FEV(1) data were incorrectly 
      collected after 2 days from the last dose of study treatment. Improvements in 
      SGRQ scores surpassed the minimum clinically important difference of more than 
      four units with both MF/F treatments. At 26 weeks, no notable between-treatment 
      differences in the occurrence and nature of adverse events (AEs) were reported. 
      No unexpected AEs were observed. Overall, 90 subjects reported AEs considered to 
      be treatment-related, the most common of which were lenticular opacities, 
      dysphonia, and oral candidiasis. DISCUSSION: In conclusion, MF/F treatments 
      improved lung function and respiratory health status, reduced exacerbations, and 
      were well tolerated in subjects with moderate-to-very severe COPD.
FAU - Doherty, Dennis E
AU  - Doherty DE
AD  - Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, 
      Lexington, KY 40536, USA. dedohe0@email.uky.edu
FAU - Tashkin, Donald P
AU  - Tashkin DP
FAU - Kerwin, Edward
AU  - Kerwin E
FAU - Knorr, Barbara A
AU  - Knorr BA
FAU - Shekar, Tulin
AU  - Shekar T
FAU - Banerjee, Sibabrata
AU  - Banerjee S
FAU - Staudinger, Heribert
AU  - Staudinger H
LA  - eng
SI  - ClinicalTrials.gov/NCT00383721
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120203
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Ethanolamines)
RN  - 0 (Pregnadienediols)
RN  - 04201GDN4R (Mometasone Furoate)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Administration, Inhalation
MH  - Adult
MH  - Area Under Curve
MH  - Bronchodilator Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Ethanolamines/*administration & dosage
MH  - Female
MH  - Formoterol Fumarate
MH  - Humans
MH  - Male
MH  - Metered Dose Inhalers
MH  - Middle Aged
MH  - Mometasone Furoate
MH  - Pregnadienediols/*administration & dosage
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/pathology
MH  - Respiratory Function Tests
MH  - Severity of Illness Index
MH  - Spirometry
MH  - Treatment Outcome
PMC - PMC3276257
OTO - NOTNLM
OT  - COPD
OT  - FEV1
OT  - bronchodilator
OT  - exacerbation
OT  - inhaled corticosteroid
OT  - spirometry
EDAT- 2012/02/16 06:00
MHDA- 2012/06/01 06:00
PMCR- 2012/02/03
CRDT- 2012/02/16 06:00
PHST- 2012/02/16 06:00 [entrez]
PHST- 2012/02/16 06:00 [pubmed]
PHST- 2012/06/01 06:00 [medline]
PHST- 2012/02/03 00:00 [pmc-release]
AID - copd-7-057 [pii]
AID - 10.2147/COPD.S27320 [doi]
PST - ppublish
SO  - Int J Chron Obstruct Pulmon Dis. 2012;7:57-71. doi: 10.2147/COPD.S27320. Epub 
      2012 Feb 3.