PMID- 23020650
OWN - NLM
STAT- MEDLINE
DCOM- 20130523
LR  - 20151119
IS  - 1541-2563 (Electronic)
IS  - 1541-2563 (Linking)
VI  - 9
IP  - 6
DP  - 2012 Dec
TI  - Efficacy of indacaterol 75 mug once-daily on dyspnea and health status: results of 
      two double-blind, placebo-controlled 12-week studies.
PG  - 629-36
LID - 10.3109/15412555.2012.729623 [doi]
AB  - Indacaterol is an inhaled, once-daily, long-acting (R)(2)-agonist for the treatment 
      of COPD. Most previous studies were conducted with doses of 150 and/or 300 mug 
      once-daily, and data with the 75 mug dose are limited. Two identically designed 
      studies were, therefore, conducted to evaluate the efficacy and safety of the 75 
      mug once-daily dose. In two double-blind studies conducted in the USA, patients 
      with moderate-to-severe COPD were randomized to treatment with indacaterol 75 mug 
      once-daily (n = 163 and 159) or matching placebo (n = 160 and 159) for 12 weeks. 
      The primary variable was forced expiratory volume in 1 s measured 24 h post-dose 
      after 12 weeks (reported elsewhere). This report describes secondary efficacy 
      endpoints, including transition dyspnea index (TDI) and St George's Respiratory 
      Questionnaire (SGRQ) total scores, and the percentages of patients with 
      improvements of or above the minimal clinically important difference (MCID; >/=1 in 
      TDI score and >/=4 in SGRQ score). Differences between indacaterol and placebo for 
      TDI total score at week 12 were 1.23 (p < 0.001) and 0.45 (p = 0.16), with odds 
      ratios for achieving the MCID of 2.19 (p = 0.002) and 1.58 (p = 0.065). SGRQ 
      total score decreased (improved) from baseline by 5.8 and 4.9 units with 
      indacaterol at week 12 (2.0 and 0.9 with placebo), with odds ratios for achieving 
      the MCID of 1.80 (p = 0.024) and 1.71 (p = 0.031). Patients receiving indacaterol 
      had statistically significant or numerical improvements in diary-derived symptom 
      variables compared with placebo. Treatment with indacaterol 75 mug may provide 
      useful improvements in patient-reported outcomes in patients with 
      moderate-to-severe COPD.
FAU - Gotfried, Mark H
AU  - Gotfried MH
AD  - Pulmonary Associates PA, Phoenix, AZ 85006, USA. mgotfried@aol.com
FAU - Kerwin, Edward M
AU  - Kerwin EM
FAU - Lawrence, David
AU  - Lawrence D
FAU - Lassen, Cheryl
AU  - Lassen C
FAU - Kramer, Benjamin
AU  - Kramer B
LA  - eng
SI  - ClinicalTrials.gov/NCT01068600
SI  - ClinicalTrials.gov/NCT01072448
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120928
PL  - England
TA  - COPD
JT  - COPD
JID - 101211769
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Indans)
RN  - 0 (Quinolones)
RN  - 8OR09251MQ (indacaterol)
SB  - IM
MH  - Administration, Inhalation
MH  - Adrenergic beta-2 Receptor Agonists/*administration & dosage/therapeutic use
MH  - Aged
MH  - Analysis of Variance
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Dyspnea/*drug therapy/etiology
MH  - Female
MH  - Forced Expiratory Volume
MH  - *Health Status Indicators
MH  - Humans
MH  - Indans/*administration & dosage/therapeutic use
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/complications/*drug therapy
MH  - Quinolones/*administration & dosage/therapeutic use
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2012/10/02 06:00
MHDA- 2013/05/25 06:00
CRDT- 2012/10/02 06:00
PHST- 2012/10/02 06:00 [entrez]
PHST- 2012/10/02 06:00 [pubmed]
PHST- 2013/05/25 06:00 [medline]
AID - 10.3109/15412555.2012.729623 [doi]
PST - ppublish
SO  - COPD. 2012 Dec;9(6):629-36. doi: 10.3109/15412555.2012.729623. Epub 2012 Sep 28.