PMID- 21397482
OWN - NLM
STAT- MEDLINE
DCOM- 20110630
LR  - 20151119
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 105
IP  - 6
DP  - 2011 Jun
TI  - Profiling the effects of indacaterol on dyspnoea and health status in patients 
      with COPD.
PG  - 892-9
LID - 10.1016/j.rmed.2011.02.013 [doi]
AB  - BACKGROUND: Indacaterol is a novel, inhaled, ultra-long-acting beta(2)-agonist 
      bronchodilator for maintenance use in patients with COPD. The aim of this paper 
      is to assess the effect of indacaterol on dyspnoea and health status, using 
      pooled study data to evaluate the relative efficacy of indacaterol and existing 
      bronchodilators. METHODS: Individual patient data were pooled from three 
      randomized, placebo-controlled studies (NCT00393458; NCT00567996; NCT00463567), 
      conducted in patients with moderate-to-severe COPD. Treatments were double-blind 
      indacaterol 150 mug (n = 746) or 300 mug (n = 853) once-daily, formoterol 12 mug 
      twice-daily (n = 556), salmeterol 50 mug twice-daily (n = 333) and placebo 
      (n = 1185); and open-label tiotropium 18 mug once-daily (n = 415). Evaluation 
      after 6 months' treatment was by transition dyspnoea index (TDI; minimum 
      clinically important difference [MCID] >/=1 point), and St George's Respiratory 
      Questionnaire (SGRQ; MCID >/=4 units). RESULTS: Differences from placebo in TDI 
      total score were 1.01 (indacaterol 150 mug) 1.28 (indacaterol 300 mug), 0.74 
      (formoterol), 0.92 (salmeterol) and 0.88 (tiotropium) (all p < 0.05), with 
      corresponding odds ratios versus placebo for exceeding the MCID from baseline of 
      1.91, 2.69, 2.02, 1.79 and 1.49 (all p < 0.05). Differences versus placebo in 
      SGRQ total score were -4.4 (indacaterol 150 mug), -3.4 (indacaterol 300 mug), -2.8 
      (formoterol), -4.0 (salmeterol) and -1.7 (tiotropium) (all p < 0.05), with 
      corresponding odds ratios versus placebo for exceeding the MCID of 1.95, 1.63, 
      1.54, 1.82 and 1.29 (all p < 0.05 apart from tiotropium). CONCLUSIONS: 
      Indacaterol provided clinically important improvements in dyspnoea and health 
      status that were at least as good as and often better than those observed with 
      existing bronchodilator treatments for COPD.
CI  - Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FAU - Jones, Paul W
AU  - Jones PW
AD  - Division of Clinical Science, St George's University of London, Cranmer Terrace, 
      London SW17 0RE, UK. pjones@sgul.ac.uk
FAU - Mahler, Donald A
AU  - Mahler DA
FAU - Gale, Rupert
AU  - Gale R
FAU - Owen, Roger
AU  - Owen R
FAU - Kramer, Benjamin
AU  - Kramer B
LA  - eng
SI  - ClinicalTrials.gov/NCT00393458
SI  - ClinicalTrials.gov/NCT00463567
SI  - ClinicalTrials.gov/NCT00567996
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20110311
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Ethanolamines)
RN  - 0 (Indans)
RN  - 0 (Quinolones)
RN  - 6EW8Q962A5 (Salmeterol Xinafoate)
RN  - 8OR09251MQ (indacaterol)
RN  - QF8SVZ843E (Albuterol)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Adrenergic beta-2 Receptor Agonists/*therapeutic use
MH  - Aged
MH  - Albuterol/*analogs & derivatives/therapeutic use
MH  - Double-Blind Method
MH  - Dyspnea/*drug therapy/metabolism/physiopathology
MH  - Ethanolamines/*therapeutic use
MH  - Female
MH  - Forced Expiratory Volume/drug effects/physiology
MH  - Formoterol Fumarate
MH  - Health Status
MH  - Humans
MH  - Indans/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/metabolism/physiopathology
MH  - Quinolones/*therapeutic use
MH  - Salmeterol Xinafoate
EDAT- 2011/03/15 06:00
MHDA- 2011/07/01 06:00
CRDT- 2011/03/15 06:00
PHST- 2010/10/12 00:00 [received]
PHST- 2011/02/10 00:00 [revised]
PHST- 2011/02/11 00:00 [accepted]
PHST- 2011/03/15 06:00 [entrez]
PHST- 2011/03/15 06:00 [pubmed]
PHST- 2011/07/01 06:00 [medline]
AID - S0954-6111(11)00062-X [pii]
AID - 10.1016/j.rmed.2011.02.013 [doi]
PST - ppublish
SO  - Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 
      11.