Onset of action of indacaterol in patients with COPD: Comparison with salbutamol and salmeterol-fluticasone
Beatrix Balint1, Henrik Watz2, Carolynn Amos3, Roger Owen3, Mark Higgins3, Benjamin Kramer4, On behalf of the INSURE* Study Investigators
1Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza, Deszk, Hungary; 2Pulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, Germany; 3Novartis Horsham Research Centre, Horsham, West Sussex, UK; 4Novartis Pharmaceuticals, East Hanover, NJ, USA; *Indacaterol: starting quickly and remaining effective in COPD
Background: Indacaterol is a novel, inhaled once-daily ultra-long-acting ß2-agonist for the treatment of chronic obstructive pulmonary disease (COPD).
Objectives: This study compared the onset of action of single doses of indacaterol 150 and 300 µg with salbutamol 200 µg, salmeterol-fluticasone 50/500 µg, and placebo in moderate-to-severe COPD patients.
Methods: This was a multicenter, randomized, double-blind, placebo-controlled crossover study. The primary variable was forced expiratory volume in one second (FEV1) at five minutes postdose.
Results: Out of 89 patients randomized (mean age 62 years), 86 completed the study. At five minutes postdose, both indacaterol doses were statistically and clinically superior to placebo (P < 0.001), with treatment–placebo differences in FEV1 of 100 (95% confidence interval [CI] 70–130) mL and 120 (95% CI 90–150) mL for indacaterol 150 and 300 µg, respectively. FEV1 at five minutes postdose with both indacaterol doses was numerically higher than for salbutamol (10 and 30 mL for indacaterol 150 and 300 µg, respectively) and significantly higher than for salmeterol-fluticasone (50 mL, P = 0.003; 70 mL, P < 0.001, respectively). Moreover, both indacaterol doses showed significantly higher FEV1 than placebo (P < 0.001) at all postdose time points. The numbers of patients with an FEV1 increase of at least 12% and 200 mL at five minutes postdose were 16 (18.8%), 24 (27.6%), 20 (23.3%), 8 (9.1%), and 3 (3.4%) for indacaterol 150 and 300 µg, salbutamol 200 µg, salmeterol-fluticasone 50/500 µg, and placebo, respectively.
Conclusions: Single doses of indacaterol 150 and 300 µg demonstrated a fast onset of action similar to that for salbutamol and faster than that for salmeterol-fluticasone.
Keywords: indacaterol, onset of action, chronic obstructive pulmonary disease
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