INDACTEROL, A NOVEL 24-HOUR b2-AGONIST, HAS A GOOD SAFETY PROFILE IN COPD PATIENTS: A 28-DAY STUDY
J Beier1, D Jack2, W Bao3 and M Higgins2
1INSAF Respiratory Research Institute (for the CQAB149B2201 Investigator Study Team), Wiesbaden, Germany; 2Novartis Horsham Research Centre, UK; 3Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Indacaterol is a novel b2-agonist providing 24h bronchodilation when given once-daily (od). This double-blind study investigated the safety and tolerability of indacaterol od for 28 days in patients with moderate-to-severe COPD.
163 patients were randomized (2:2:1) to receive indacaterol 400 or 800μg or placebo od via single-dose DPI. Safety was assessed on Days 1, 14 & 28.
Incidence and nature of AEs were as expected for this type of study/population. AEs (none serious) were reported by 35% (400μg), 51% (800μg) and 25% (placebo) of patients. Respiratory, thoracic, mediastinal AEs were most frequent. β2-mediated AEs (headache, tremor) showed little evidence of dose relationship.
There was no evidence of an effect on notable QTc values (Bazett
s), with an increase >60ms post baseline experienced by 1 patient each in 800μg and placebo groups.
There were no clinically relevant differences in haematology, glucose or K+ levels, or pulse rate, and no drug-related trends or major differences in blood pressure.
Indacaterol (400 or 800 µg od for 28 days) demonstrated a good safety profile with no clinically relevant effects on potassium, glucose, pulse rate or blood pressure. Indacaterol had no significant effect on QTc signal.
Back to Abstracts Menu
