Source: Annual Congress 2012 - COPD treatments: efficacy and safety
Disease area: Airway diseases

Abstract

Rationale
The efficacy and safety of indacaterol (IND), a once-daily (qd) inhaled LABA for the treatment of COPD, was investigated in a predominantly Chinese COPD popn.
Methods
This double-blind placebo (PBO)-controlled 26-week study, randomized pts with moderate-to-severe COPD (≥40 yrs, post-bd FEV₁/FVC<70%, FEV₁≥30 to <80% pred, smoking history ≥10 pack-years) to IND 150 or 300 μg or PBO qd. Variables included trough FEV₁ (mean of 23h 10min and 23h 45min post-dose) at Wk12 (primary) and 26; and health status (St George‘s Respiratory Questionnaire; SGRQ) and transition dyspnea index (TDI) at Week 26.
Results
Of 563 pts randomized (89.8% Chinese, 94.3% male, mean age 65.4 yrs, post-bd FEV₁ 49.9% pred), 85.6% completed. Both IND doses significantly improved trough FEV₁ vs PBO (p<0.001), with IND-PBO diffs exceeding the prespecified MCID (0.12L) at Wk12 (0.15 & 0.13L for 150 & 300 µg) and Wk26 (both 0.13L). TDI total score at Wk26 was superior to PBO for both IND doses (0.82 & 1.15, p<0.01), as was % pts with a clinically relevant (≥1 point) TDI score (74.1 & 78.6% vs 55.5%, p<0.05 for IND 150 & 300µg vs PBO). Both doses provided improvements (i.e., decreases) from baseline in SGRQ total score of ≥4 units at Wk26 that were numerically greater than with PBO (raw mean changes: –9.6 & –8.8 vs –7.0 units), with a similar pattern in the % of pts with a clinically relevant SGRQ score (≤–4 units; 65.0 & 61.5% vs 60.6%). The incidence of AEs was 49.2%, 54.3% & 45.2% for IND 150, 300µg & PBO.
Conclusion
Indacaterol provided effective bronchodilation in this predominantly Chinese population, with significant improvements in breathlessness and a trend towards improved health status.

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W. Yao, C. Wang, N. Zhong, W. Yang, M. Henley, B. Kramer (Beijing, Chongqing, Guangzhou, China; East Hanover, United States Of America; Horsham, United Kingdom). Effect of once-daily indacaterol in a predominantly Chinese COPD population: A 26-week Asia-Pacific study. Eur Respir J 2012; 40: Suppl. 56, 2107

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