Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease--a randomized, multicenter, double-blind, placebo-controlled study

Henrik Watz, Felix Krippner, Anne Kirsten, Helgo Magnussen, Claus Vogelmeier, Henrik Watz, Felix Krippner, Anne Kirsten, Helgo Magnussen, Claus Vogelmeier

Abstract

Background: Indacaterol is a long-acting beta-2 agonist for once-daily treatment of COPD. We evaluated the effects of indacaterol 150 μg on lung hyperinflation compared with placebo and open-label tiotropium 18 μg. We measured physical activity during treatment with indacaterol 150 μg and matched placebo.

Methods: We performed a randomized, three-period, cross-over study (21 days of treatment separated by two wash-out periods of 13 days) with indacaterol 150 μg or matching placebo and tiotropium 18 μg. Lung function was assessed by body plethysmography and spirometry. Physical activity was measured for one week by a multisensory armband at the end of both treatment periods with indacaterol/matched placebo. The primary endpoint was peak inspiratory capacity at the end of each treatment period.

Results: 129 patients (mean age, 61 years; mean post-bronchodilator FEV1, 64%), were randomized and 110 patients completed the study. Peak inspiratory capacity was 0.22 L greater with Indacaterol at day 21 compared to placebo (p < 0.001). Similar results were observed for tiotropium. Both bronchodilators also significantly improved other parameters of lung hyperinflation compared with placebo. All parameters of physical activity were significantly increased during treatment with indacaterol versus placebo.

Conclusions: Indacaterol 150 μg improved lung hyperinflation in patients with moderate COPD, which was associated with an increase of physical activity.

Trial registration: ClinicalTrials.gov registration number: NCT01012765.

Figures

Figure 1
Figure 1
Effect of indacaterol and tiotropium versus placebo on peak inspiratory capacity (IC) on Day 21. ***p < 0.001 vs placebo; #non-inferiority to tiotropium. Data are least square mean ± 95% CI for FAS population (n = 129).
Figure 2
Figure 2
Effect of indacaterol and tiotropium versus placebo in trough inspiratory capacity (IC) on Day 20. ***p < 0.001 vs placebo; #non-inferiority to tiotropium. Data are least square mean ± 95% CI for FAS population (n = 129).
Figure 3
Figure 3
Effect of indacaterol on physical activity during treatment. (a) Steps per day (n=83) (b) Minutes of at least moderate physical activity (n=83).

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