ARTICLE | Clinical News

Study shows indacaterol non-inferior to Spiriva in COPD

November 4, 2010 12:06 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said 150 ug once-daily indacaterol met the primary endpoint of non-inferiority to once-daily Spiriva HandiHaler tiotropium in the Phase III INTENSITY trial to treat moderate to severe chronic obstructive pulmonary disease (COPD). The adrenergic receptor beta 2 agonist produced a 1.44 L baseline-adjusted trough forced expiratory volume in one second (FEV1) at week 12 vs. 1.43 L for Spiriva (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. Data were presented at the American College of Chest Physicians meeting in Vancouver. ...