24-hour bronchodilator efficacy of single doses of indacaterol in patients with persistent asthma: comparison with placebo and formoterol.
OBJECTIVE
To assess the 24-h bronchodilator efficacy and safety of single-dose indacaterol in asthma.


METHODS
This was a five-period, double-blind, double-dummy, crossover study in patients with persistent asthma. On separate study days, patients inhaled a single dose of indacaterol (150, 300 or 600 microg) in the morning via a single-dose dry powder inhaler (SDDPI), formoterol 12 microg twice daily via its proprietary SDDPI, or placebo. Study days were separated by a washout period of at least 6 days.


RESULTS
Of the 45 patients randomized to treatment, 42 completed the study. The 24-h trough FEV(1) (primary endpoint) was significantly higher than placebo following all doses of indacaterol (mean [95% CI] differences of 0.11 [0.06, 0.16], 0.21 [0.17, 0.26] and 0.22 [0.18, 0.27] L for 150, 300, and 600 microg, respectively) and formoterol (by 0.13 [0.08, 0.18] L). The 24-h trough FEV(1) was significantly higher following indacaterol 300 and 600 microg than indacaterol 150 microg (by 0.11 [0.06, 0.15] and 0.12 [0.07, 0.17] L, respectively) or formoterol (by 0.08 [0.03, 0.13] L vs. 300 microg; by 0.09 [0.04, 0.14] L vs. 600 microg). Most adverse events were mild-to-moderate and transient. Examination of serum potassium, blood glucose, QTc interval, pulse rate, and blood pressure raised no concern over the safety of indacaterol.


CONCLUSIONS
Single doses of indacaterol provided effective 24-h bronchodilation and were well tolerated in patients with persistent asthma. Safety findings were limited by non-standardized diet conditions in this study but suggest a minimal systemic treatment effect.
LaForce
Craig
C
North Carolina Clinical Research, 4301 Lake Boone Trail, Suite 309A, Raleigh, North Carolina 27607, USA. claforce@carolinaallergyasthma.com
Korenblat
Phillip
P
Osborne
Pamela
P
Dong
Fang
F
Higgins
Mark
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D015363:Quinolones / Q000627:therapeutic use*; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D004983:Ethanolamines; D007189:Indans; D010919:Placebos; D015363:Quinolones; C510790:indacaterol; D000068759:Formoterol Fumarate