PMID- 21848706
OWN - NLM
STAT- MEDLINE
DCOM- 20120119
LR  - 20221207
IS  - 1440-1843 (Electronic)
IS  - 1323-7799 (Linking)
VI  - 16
IP  - 8
DP  - 2011 Nov
TI  - Roflumilast in Asian patients with COPD: A randomized placebo-controlled trial.
PG  - 1249-57
LID - 10.1111/j.1440-1843.2011.02038.x [doi]
AB  - BACKGROUND AND OBJECTIVE: Roflumilast, an oral, selective phosphodiesterase 4 
      inhibitor, has been shown to reduce exacerbations and improve pulmonary function 
      in patients with COPD. This study examined the efficacy, safety and tolerability 
      of roflumilast in Asian patients with COPD. METHODS: Patients with COPD were 
      randomized 1:1 to enter a 12-week treatment period and receive either oral 
      roflumilast, 500 microg once daily, or placebo, following a single-blind, 4-week 
      baseline period in which all patients received placebo. The primary end point was 
      mean change in FEV(1) from baseline to each postrandomization visit during the 
      treatment period. Other spirometric lung function measurements were evaluated as 
      secondary end points. COPD exacerbations were monitored. Safety was assessed from 
      clinical laboratory tests, vital signs, physical examination (including 
      electrocardiogram) and monitoring of adverse events (AEs). RESULTS: Of 551 
      patients recruited, 410 were randomized and received at least one dose of study 
      medication (roflumilast, n = 203; placebo, n = 207). Superiority of roflumilast 
      over placebo was demonstrated by a statistically significant difference in 
      postbronchodilator FEV(1) (79 mL, P < 0.0001). Other spirometry end points, 
      including prebronchodilator FEV(1), pre-and postbronchodilator FEV(6), forced vital 
      capacity and peak expiratory flow significantly favoured roflumilast over 
      placebo. AEs were more common with roflumilast than with placebo, but were 
      comparable with those reported in previous studies. CONCLUSIONS: Roflumilast, 500 
      microg once daily, improves pulmonary function in Asian patients with COPD. The 
      safety and tolerability of roflumilast in this population was similar to that in 
      a Caucasian population.
CI  - (c) 2011 The Authors. Respirology (c) 2011 Asian Pacific Society of Respirology.
FAU - Lee, Sang-Do
AU  - Lee SD
AD  - Asan Medical Center, Seoul, South Korea.
FAU - Hui, David S C
AU  - Hui DS
FAU - Mahayiddin, Aziah A
AU  - Mahayiddin AA
FAU - Roa, Camilo C Jr
AU  - Roa CC Jr
FAU - Kwa, Kheng Hoe
AU  - Kwa KH
FAU - Goehring, Udo-Michael
AU  - Goehring UM
FAU - Bredenbroker, Dirk
AU  - Bredenbroker D
FAU - Kuo, Han-Pin
AU  - Kuo HP
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Australia
TA  - Respirology
JT  - Respirology (Carlton, Vic.)
JID - 9616368
RN  - 0 (Aminopyridines)
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Benzamides)
RN  - 0 (Cyclopropanes)
RN  - 0 (Phosphodiesterase 4 Inhibitors)
RN  - 0P6C6ZOP5U (Roflumilast)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aminopyridines/*therapeutic use
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - *Asian People
MH  - Benzamides/*therapeutic use
MH  - Cyclopropanes/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume/*drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase 4 Inhibitors/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/ethnology/physiopathology
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Vital Capacity/*drug effects
EDAT- 2011/08/19 06:00
MHDA- 2012/01/20 06:00
CRDT- 2011/08/19 06:00
PHST- 2011/08/19 06:00 [entrez]
PHST- 2011/08/19 06:00 [pubmed]
PHST- 2012/01/20 06:00 [medline]
AID - 10.1111/j.1440-1843.2011.02038.x [doi]
PST - ppublish
SO  - Respirology. 2011 Nov;16(8):1249-57. doi: 10.1111/j.1440-1843.2011.02038.x.