PMID- 20211002
OWN - NLM
STAT- MEDLINE
DCOM- 20100423
LR  - 20231103
IS  - 1471-2466 (Electronic)
IS  - 1471-2466 (Linking)
VI  - 10
DP  - 2010 Mar 8
TI  - Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, 
      randomised, 12-week study.
PG  - 11
LID - 10.1186/1471-2466-10-11 [doi]
AB  - BACKGROUND: Indacaterol is a novel, once-daily (o.d.) inhaled, long-acting 
      beta2-agonist in development for chronic obstructive pulmonary disease (COPD). 
      This 12-week, double-blind study compared the efficacy, safety, and tolerability 
      of indacaterol to that of placebo in patients with moderate-to-severe COPD. 
      METHODS: Efficacy variables included 24-h trough FEV1 (mean of 23 h 10 min and 23 
      h 45 min post-dose) at Week 12 (primary endpoint) and after Day 1, and the 
      percentage of COPD days with poor control (i.e., worsening symptoms). Safety was 
      assessed by adverse events (AEs), mean serum potassium and blood glucose, QTc 
      (Fridericia), and vital signs. RESULTS: Patients were randomised (n = 416, mean 
      age 63 years) to receive either indacaterol 150 microg o.d. (n = 211) or placebo 
      (n = 205) via a single-dose dry-powder inhaler; 87.5% completed the study. Trough 
      FEV1 (LSM +/- SEM) at Week 12 was 1.48 +/- 0.018 L for indacaterol and 1.35 +/- 
      0.019 L for placebo, a clinically relevant difference of 130 +/- 24 mL (p < 
      0.001). Trough FEV1 after one dose was significantly higher with indacaterol than 
      placebo (p < 0.001). Indacaterol demonstrated significantly higher peak FEV1 than 
      placebo, both on Day 1 and at Week 12, with indacaterol-placebo differences (LSM 
      +/- SEM) of 190 +/- 28 (p < 0.001) and 160 +/- 28 mL (p < 0.001), respectively. 
      Standardised AUC measurements for FEV1 (between 5 min and 4 h, 5 min and 1 h, and 
      1 and 4 h post-dose) at Week 12 were all significantly greater with indacaterol 
      than placebo (p < 0.001), with LSM (+/- SEM) differences of 170 +/- 24, 180 +/- 
      24, and 170 +/- 24 mL, respectively. Indacaterol significantly reduced the 
      percentage of days of poor control versus placebo by 22.5% (p < 0.001) and was 
      also associated with significantly reduced use of rescue medication (p < 0.001). 
      The overall rates of AEs were comparable between the groups (indacaterol 49.3%, 
      placebo 46.8%), with the most common AEs being COPD worsening (indacaterol 8.5%, 
      placebo 12.2%) and cough (indacaterol 6.2%, placebo 7.3%). One patient died in 
      the placebo group. Serum potassium and blood glucose levels did not differ 
      significantly between the two groups, and no patient had QTc >500 ms. 
      CONCLUSIONS: Indacaterol 150 microg o.d. provided clinically significant and 
      sustained bronchodilation, reduced rescue medication use, and had a safety and 
      tolerability profile similar to placebo. TRIAL REGISTRATION: NCT00624286.
FAU - Feldman, Gregory
AU  - Feldman G
AD  - S. Carolina Pharmaceutical Research, Spartanburg, SC, USA.
FAU - Siler, Thomas
AU  - Siler T
FAU - Prasad, Niyati
AU  - Prasad N
FAU - Jack, Damon
AU  - Jack D
FAU - Piggott, Simon
AU  - Piggott S
FAU - Owen, Roger
AU  - Owen R
FAU - Higgins, Mark
AU  - Higgins M
FAU - Kramer, Benjamin
AU  - Kramer B
CN  - INLIGHT 1 study group
LA  - eng
SI  - ClinicalTrials.gov/NCT00624286
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20100308
PL  - England
TA  - BMC Pulm Med
JT  - BMC pulmonary medicine
JID - 100968563
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Indans)
RN  - 0 (Placebos)
RN  - 0 (Quinolones)
RN  - 8OR09251MQ (indacaterol)
SB  - IM
MH  - *Adrenergic beta-2 Receptor Agonists
MH  - Aged
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indans/*administration & dosage/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - *Patient Satisfaction
MH  - Placebos
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Quinolones/*administration & dosage/*adverse effects
MH  - Treatment Outcome
PMC - PMC2848004
EDAT- 2010/03/10 06:00
MHDA- 2010/04/24 06:00
PMCR- 2010/03/08
CRDT- 2010/03/10 06:00
PHST- 2009/07/31 00:00 [received]
PHST- 2010/03/08 00:00 [accepted]
PHST- 2010/03/10 06:00 [entrez]
PHST- 2010/03/10 06:00 [pubmed]
PHST- 2010/04/24 06:00 [medline]
PHST- 2010/03/08 00:00 [pmc-release]
AID - 1471-2466-10-11 [pii]
AID - 10.1186/1471-2466-10-11 [doi]
PST - epublish
SO  - BMC Pulm Med. 2010 Mar 8;10:11. doi: 10.1186/1471-2466-10-11.