PMID- 23040786
OWN - NLM
STAT- MEDLINE
DCOM- 20130222
LR  - 20151119
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 106
IP  - 12
DP  - 2012 Dec
TI  - Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week 
      study in an Asian population.
PG  - 1715-21
LID - S0954-6111(12)00343-5 [pii]
LID - 10.1016/j.rmed.2012.09.002 [doi]
AB  - INTRODUCTION: This post hoc analysis evaluated the efficacy of indacaterol, a 
      novel inhaled once-daily long-acting beta(2)-agonist, by disease severity (GOLD 
      2005) in patients with moderate-to-severe COPD from six Asian countries/areas 
      (Hong Kong, India, Japan, Korea, Singapore, Taiwan). METHODS: Data from a 
      12-week, double-blind, placebo-controlled, parallel-group study in patients 
      randomized to indacaterol 150 mug, indacaterol 300 mug or placebo once daily were 
      analyzed based on baseline disease severity (moderate or severe). Endpoints were: 
      trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), 
      transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) 
      at Week 12. Safety data were collected. RESULTS: Of 347 patients randomized, 
      59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) 
      indacaterol-placebo differences in trough FEV(1) at Week 12 exceeded the 
      pre-specified minimal clinically important difference (MCID) of 0.12L and were 
      statistically superior (p < 0.001) for indacaterol (150 mug, 300 mug) versus 
      placebo in the two subgroups [0.19L, 0.20L (moderate); 0.15L, 0.19L (severe) 
      respectively]. LSM TDI scores for both indacaterol doses versus placebo in both 
      subgroups were statistically superior (p < 0.05) and clinically meaningful (>/=1 
      unit). Both indacaterol doses showed improvements in LSM SGRQ total scores at 
      Week 12 which exceeded the MCID (4 units) versus placebo in both subgroups, with 
      indacaterol 300 mug-placebo difference in the severe subgroup being statistically 
      significant (p < 0.01). Overall incidence of adverse events was lower with 
      indacaterol than with placebo across both subgroups. CONCLUSIONS: Indacaterol 
      demonstrated clinically relevant improvements versus placebo in lung function, 
      dyspnea and health status in Asian COPD patients irrespective of disease 
      severity. CLINICAL TRIALS IDENTIFIER: NCT00794157.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - To, Yasuo
AU  - To Y
AD  - The Fraternity Memorial Hospital, Tokyo, Japan.
FAU - Kinoshita, Masaharu
AU  - Kinoshita M
FAU - Lee, Sang Haak
AU  - Lee SH
FAU - Hang, Liang-Wen
AU  - Hang LW
FAU - Ichinose, Masakazu
AU  - Ichinose M
FAU - Fukuchi, Yoshinosuke
AU  - Fukuchi Y
FAU - Kitawaki, Tetsuji
AU  - Kitawaki T
FAU - Okino, Naoko
AU  - Okino N
FAU - Prasad, Niyati
AU  - Prasad N
FAU - Lawrence, David
AU  - Lawrence D
FAU - Kramer, Benjamin
AU  - Kramer B
LA  - eng
SI  - ClinicalTrials.gov/NCT00794157
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20121005
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Indans)
RN  - 0 (Quinolones)
RN  - 8OR09251MQ (indacaterol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asia/ethnology
MH  - Bronchodilator Agents/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Dyspnea/prevention & control
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Health Status
MH  - Humans
MH  - Indans/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/ethnology
MH  - Quinolones/*administration & dosage/adverse effects
MH  - Sleep Wake Disorders/prevention & control
MH  - Treatment Outcome
MH  - Vital Capacity/drug effects
EDAT- 2012/10/09 06:00
MHDA- 2013/02/23 06:00
CRDT- 2012/10/09 06:00
PHST- 2012/03/20 00:00 [received]
PHST- 2012/08/30 00:00 [revised]
PHST- 2012/09/05 00:00 [accepted]
PHST- 2012/10/09 06:00 [entrez]
PHST- 2012/10/09 06:00 [pubmed]
PHST- 2013/02/23 06:00 [medline]
AID - S0954-6111(12)00343-5 [pii]
AID - 10.1016/j.rmed.2012.09.002 [doi]
PST - ppublish
SO  - Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 
      Oct 5.