Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium.
BACKGROUND
Evidence has been provided that high-dose indacaterol (300 μg) can reduce lung hyperinflation in moderate-to-severe chronic obstructive pulmonary disease (COPD).


OBJECTIVE
To study whether low-dose indacaterol (150 μg) also reduces lung hyperinflation in comparison with the recommended dose of tiotropium (18 μg) in moderate COPD.


METHODS
This was a multicenter, randomized, blinded, 3-period cross-over, placebo-controlled study. Spirometry and lung volumes were measured before and 30, 60, 120, 180 and 240 min after the administration of single-doses of indacaterol, tiotropium, or placebo. The primary end-point was the change in peak inspiratory capacity (IC). The area under the 4-h curve (AUC(0-4)) for IC, 1-s forced expiratory volume (FEV(1)) and forced vital capacity (FVC) were secondary variables.


RESULTS
49 patients completed the study. On average, peak IC and AUC(0-4) for IC were significantly greater after indacaterol than placebo by 177 mL (p = 0.007) and 142 mL (p = 0.001), respectively. Differences in peak IC and AUC(0-4) for IC between tiotropium and placebo were 120 mL (p = 0.07) and 85 mL (p = 0.052), respectively. Differences between indacaterol and tiotropium were statistically insignificant. Peak IC increased by >20% in 12 patients with indacaterol and 9 with tiotropium (p = 0.001), and by >30% in 8 patients with indacaterol and 3 with tiotropium (p = 0.001). The effects of indacaterol and tiotropium on FEV(1) and FVC were statistically significant vs placebo.


CONCLUSIONS
Low-dose indacaterol has a bronchodilator effect that is similar to the recommended dose of tiotropium, but it is slightly superior in reducing lung hyperinflation.


BACKGROUND
ClinicalTrials.gov number: NCT00999908.
Unità Operativa Complessa di Pneumologia, Azienda Ospedaliera Universitaria Integrata, Verona, Italy. andrea.rossi2@ospedaleuniverona.it
Andrea
A
Rossi
Stefano
S
Centanni
Isa
I
Cerveri
Carlo
C
Gulotta
Antonio
A
Foresi
Mario
M
Cazzola
Vito
V
Brusasco
D000368:Aged; D019540:Area Under Curve; D001993:Bronchodilator Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007189:Indans / Q000494:pharmacology / Q000627:therapeutic use*; D007320:Inspiratory Capacity / Q000187:drug effects; D008176:Lung Volume Measurements; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology*; D015363:Quinolones / Q000494:pharmacology / Q000627:therapeutic use*; D012602:Scopolamine Derivatives / Q000494:pharmacology / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013147:Spirometry; D013997:Time Factors; D000069447:Tiotropium Bromide; D014797:Vital Capacity
D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; D012602:Scopolamine Derivatives; C510790:indacaterol; D000069447:Tiotropium Bromide