INDACATEROL, A NOVEL 24-HOUR b2-AGONIST, IS EFFECTIVE AND WELL TOLERATED IN 14-DAY STUDY IN PATIENTS WITH MILD-TO-MODERATE COPD
M Aubier1, X Duval1, H Knight2, S Perry2, J Wood2, L Brookman2 and S Pascoe2
1Clinical Investigating Center 007, Hôpital Bichat, Paris, France; 2Novartis Horsham Research Centre, UK
Indacaterol is a novel inhaled b2-agonist providing 24h bronchodilation with once-daily (od) dosing. A randomized, double-blind, parallel-group study investigated the safety and tolerability of indacaterol in patients with mild to moderate COPD.
12 patients received indacaterol 800 mg (n=8) or placebo (n=4) via HFA MDI od for 14 days. Safety (AEs, vital signs, ECGs, lab tests, physical exams), pharmacodynamics (FEV1) and pharmacokinetics were recorded on Days 1, 7 & 14.
Most patients did not experience an AE, and none discontinued owing to AEs. The AEs experienced were usually mild, not suspected to be study drug related, and required no action. There were no treatment effects on pulse rate, QTc (Fridericia’s or Bazett’s), serum glucose or potassium.
Indacaterol had a 24h bronchodilator duration. Efficacy was maintained throughout the 14-day treatment period.
Indacaterol median tmax was 0.5–1h on Days 1, 7 & 14. Systemic exposure (AUC0–24h) increased about 2-fold from Day 1–14. Mean t½ was 48h.
Indacaterol 800 µg od for 14 days was well tolerated, with no serious or severe AEs. Indacaterol has a 24h duration of action, with efficacy maintained on multiple dosing.
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