PMID- 18219838
OWN - NLM
STAT- MEDLINE
DCOM- 20080219
LR  - 20141120
IS  - 1081-1206 (Print)
IS  - 1081-1206 (Linking)
VI  - 99
IP  - 6
DP  - 2007 Dec
TI  - Tolerability of indacaterol, a novel once-daily beta2-agonist, in patients with 
      asthma: a randomized, placebo-controlled, 28-day safety study.
PG  - 555-61
LID - 10.1016/S1081-1206(10)60386-9 [doi]
AB  - BACKGROUND: Indacaterol is a novel, inhaled, once-daily beta2-agonist. OBJECTIVE: 
      To investigate the safety and tolerability of indacaterol at doses of 400 and 800 
      microg/d. METHODS: Randomized, double-blind, placebo-controlled, parallel-group, 
      multicenter, 28-day study. Patients with persistent asthma (forced expiratory 
      volume in 1 second [FEV1] > or =-60% predicted, < or =1,600 microg of 
      beclomethasone dipropionate or equivalent daily) received indacaterol, 400 microg 
      (n = 59) or 800 microg (n = 59), or placebo (n = 26) once daily via a single-dose 
      dry powder inhaler. Safety assessments were performed before and after dosing on 
      days 1, 14, and 28, with particular attention to key beta2-agonist safety 
      variables. RESULTS: A total of 144 patients were randomized, with 135 (93.8%) 
      completing the study. Indacaterol was well tolerated: the incidence of adverse 
      events (AEs) was similar between the active and placebo groups, and AEs, when 
      they occurred, were mild or moderate for most (98.2%). There was no dose-response 
      relationship between indacaterol and the incidence of AEs (400 microg, 40.7%; 800 
      microg, 37.3%; and placebo, 38.5%). Few AEs considered as beta2-agonist class 
      effects occurred (none leading to withdrawal). Small differences between 
      indacaterol and placebo in mean serum potassium (< or =-0.29 mmol/L) and glucose 
      (< or =0.93 mmol/L) levels were occasionally statistically significant (P < .05) 
      but not regarded as clinically meaningful. As expected for a beta2-agonist, there 
      was some indication of a trend in QTc prolongation with increasing exposure 
      (maximum mean change, 8.9 milliseconds; P < .05 vs placebo). Significant 
      increases in FEV1 (P < .05) were seen at all postbaseline time points for both 
      indacaterol doses vs placebo, with indacaterol-placebo differences 30 minutes 
      after dosing of 0.21 to 0.25 L and before dosing on days 14 and 28 (approximately 
      24 hours after the previous dose) of 0.15 to 0.23 L. CONCLUSION: Indacaterol had 
      a good overall safety profile and was well tolerated at both doses, with predose 
      FEV1 results on days 14 and 28 indicating 24-hour bronchodilator efficacy.
FAU - Yang, William H
AU  - Yang WH
AD  - Allergy and Asthma Research Centre, Ottawa, Ontario, Canada. 
      wyang@yangmedicine.com
FAU - Martinot, Jean Benoit
AU  - Martinot JB
FAU - Pohunek, Petr
AU  - Pohunek P
FAU - Beier, Jutta
AU  - Beier J
FAU - Magula, Daniel
AU  - Magula D
FAU - Cameron, Ray
AU  - Cameron R
FAU - Owen, Roger
AU  - Owen R
FAU - Higgins, Mark
AU  - Higgins M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Adrenergic beta-Agonists)
RN  - 0 (Blood Glucose)
RN  - 0 (Indans)
RN  - 0 (Quinolones)
RN  - 8OR09251MQ (indacaterol)
RN  - RWP5GA015D (Potassium)
SB  - IM
MH  - Adolescent
MH  - Adrenergic beta-Agonists/*administration & dosage/adverse effects
MH  - Adult
MH  - Aged
MH  - Asthma/blood/*drug therapy/physiopathology
MH  - Blood Glucose/metabolism
MH  - Child
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Electrocardiography/drug effects
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Indans/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Potassium/blood
MH  - Quinolones/*administration & dosage/adverse effects
EDAT- 2008/01/29 09:00
MHDA- 2008/02/20 09:00
CRDT- 2008/01/29 09:00
PHST- 2008/01/29 09:00 [pubmed]
PHST- 2008/02/20 09:00 [medline]
PHST- 2008/01/29 09:00 [entrez]
AID - S1081-1206(10)60386-9 [pii]
AID - 10.1016/S1081-1206(10)60386-9 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2007 Dec;99(6):555-61. doi: 
      10.1016/S1081-1206(10)60386-9.