Evidence has been provided that high-dose indacaterol (300 μg) can reduce lung hyperinflation in moderate-to-severe chronic obstructive pulmonary disease (COPD).AimTo 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 (AUC0–4) for IC, 1-s forced expiratory volume (FEV1) and forced vital capacity (FVC) were secondary variables.

Results : 49 patients completed the study. On average, peak IC and AUC0–4for 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 AUC0–4for 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 FEV1and 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.

Trial registration Clinical Trials. govnumber: NCT00999908.

Author : Andrea Rossi, Stefano Centanni, Isa Cerveri, Carlo Gulotta, Antonio Foresi, ...
Publication year: 2011
Source: Respiratory Medicine, Available online 27 October 2011
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