PMID- 17088091
OWN - NLM
STAT- MEDLINE
DCOM- 20080129
LR  - 20141120
IS  - 1094-5539 (Print)
IS  - 1094-5539 (Linking)
VI  - 20
IP  - 6
DP  - 2007
TI  - Safety, tolerability and efficacy of indacaterol, a novel once-daily 
      beta(2)-agonist, in patients with COPD: a 28-day randomised, placebo controlled 
      clinical trial.
PG  - 740-9
AB  - In patients with chronic obstructive pulmonary disease (COPD) classified as 
      moderate onwards, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 
      Guidelines recommend regular treatment with one or more long-acting 
      bronchodilators, such as beta(2)-agonists or anticholinergics. In contrast to 
      currently available long-acting beta(2)-agonists, which have a duration of action 
      of 12 h, indacaterol has demonstrated effective 24-h bronchodilation on 
      once-daily dosing. A double-blind, randomised, placebo-controlled study was 
      conducted to compare the safety, tolerability and efficacy of indacaterol with 
      that of placebo, over a 28-day period, in patients with moderate COPD (as defined 
      by GOLD 2001 criteria; equivalent to moderate-to-severe COPD in the GOLD 2005 
      criteria). Patients were randomised 2:2:1 to receive indacaterol 400 microg or 
      800 microg or placebo once-daily (between 07:00 and 11:00 h) via a single-dose 
      dry-powder inhaler for 28 days. Assessments included monitoring of adverse events 
      (AEs), blood chemistry (including serum potassium and blood glucose), vital signs 
      (blood pressure and heart rate), electrocardiograms and spirometry. One hundred 
      and sixty-three patients were randomised, with 155 (95%) completing the study. 
      There were no statistically significant differences between treatment groups in 
      the overall incidence of AEs, with AEs reported by 35%, 51% and 25% of patients 
      in the indacaterol 400 microg, 800 microg and placebo groups, respectively. The 
      majority of AEs were mild or moderate in severity, and there were no study-drug 
      related serious AEs. There were no statistically significant differences between 
      indacaterol groups and placebo in mean pulse rate and QTc interval, and isolated 
      statistically significant (p<0.05) treatment-placebo differences in mean blood 
      pressure, blood glucose and serum potassium. There was a statistically 
      significant improvement in FEV(1) vs placebo at all post-baseline timepoints for 
      both indacaterol treatment groups; 30 min post-dose, adjusted mean+/-SE FEV(1) 
      indacaterol-placebo differences were: Day 1, 220+/-36 ml and 210+/-36 ml; Day 14, 
      320+/-50 ml and 270+/-50 ml; Day 28, 260+/-61 ml and 200+/-61 ml for 400 and 800 
      microg, respectively (all p<0.01 vs placebo). Bronchodilation was still apparent 
      after 24h, with pre-dose (i.e. trough) adjusted mean+/-SE FEV(1) 
      indacaterol-placebo differences of: Day 14, 230+/-44 ml and 210+/-44 ml; Day 28, 
      220+/-49 ml and 210+/-49 ml for indacaterol 400 and 800 microg, respectively (all 
      p<0.0001 vs placebo). Once-daily indacaterol was well tolerated at doses up to 
      800 microg with a good overall safety profile. There was no statistical 
      difference at any dose between the safety of indacaterol and placebo. 
      Furthermore, this study supports the previously demonstrated 24-h bronchodilator 
      efficacy of indacaterol.
FAU - Beier, Jutta
AU  - Beier J
AD  - insaf Respiratory Research Institute, Biebricher Allee 34, D-65187 Wiesbaden, 
      Germany. j.beier@insaf-wi.de
FAU - Chanez, Pascal
AU  - Chanez P
FAU - Martinot, Jean-Benoit
AU  - Martinot JB
FAU - Schreurs, A J M
AU  - Schreurs AJ
FAU - Tkacova, Ruzena
AU  - Tkacova R
FAU - Bao, Weibin
AU  - Bao W
FAU - Jack, Damon
AU  - Jack D
FAU - Higgins, Mark
AU  - Higgins M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20060930
PL  - England
TA  - Pulm Pharmacol Ther
JT  - Pulmonary pharmacology & therapeutics
JID - 9715279
RN  - 0 (Adrenergic beta-Agonists)
RN  - 0 (Blood Glucose)
RN  - 0 (Indans)
RN  - 0 (Quinolones)
RN  - 8OR09251MQ (indacaterol)
RN  - RWP5GA015D (Potassium)
SB  - IM
MH  - Administration, Inhalation
MH  - Adrenergic beta-Agonists/administration & dosage/adverse effects/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Blood Pressure/drug effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Electrocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - Forced Expiratory Volume/drug effects
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Indans/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nebulizers and Vaporizers
MH  - Potassium/blood
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Quinolones/administration & dosage/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Time Factors
EDAT- 2006/11/08 09:00
MHDA- 2008/01/30 09:00
CRDT- 2006/11/08 09:00
PHST- 2006/03/15 00:00 [received]
PHST- 2006/09/05 00:00 [revised]
PHST- 2006/09/15 00:00 [accepted]
PHST- 2006/11/08 09:00 [pubmed]
PHST- 2008/01/30 09:00 [medline]
PHST- 2006/11/08 09:00 [entrez]
AID - S1094-5539(06)00098-8 [pii]
AID - 10.1016/j.pupt.2006.09.001 [doi]
PST - ppublish
SO  - Pulm Pharmacol Ther. 2007;20(6):740-9. doi: 10.1016/j.pupt.2006.09.001. Epub 2006 
      Sep 30.