Onbrez Breezhaler indacaterol: Phase III data

In the double-blind, double-dummy, international Phase III INTENSITY trial in 1,598 patients, 150 µg once-daily indacaterol met the primary endpoint of non-inferiority to 18 µg once-daily Spiriva HandiHaler tiotropium in baseline-adjusted trough FEV1 at week 12 (1.44 vs. 1.43 L, p<0.001 for non-inferiority). Indacaterol missed the secondary endpoint of superiority to Spiriva in FEV1, but was superior to Spiriva on the secondary endpoint of significantly improving breathlessness as measured by transition dyspnea index total score at week 12 (2.01 vs. 1.43, p<0.001). Indacaterol also significantly reduced the amount of albuterol rescue medication used (-1.4 vs. -0.85 puffs/day, p<0.001), increased the number of days in which patients required no rescue medication (46.1 vs. 41.4, p=0.004), and improved SGRQ scores from baseline to week 12 vs. Spiriva (5.1 vs. 3, p<0.001).

Indacaterol was well tolerated with a similar incidence of adverse events between treatment groups (39.7% vs. 37.2%). The most common adverse events were COPD worsening, cough and nasopharyngitis. Overall, 2.8% of indacaterol-treated patients experienced a serious adverse event vs. 3.8% for Spiriva. Data were presented at the American College of Chest Physicians meeting in Vancouver. ...