RT Journal Article
SR Electronic
T1 Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP erj01918-2010
DO 10.1183/09031936.00191810
A1 R. Buhl
A1 L.J. Dunn
A1 C. Disdier
A1 C. Lassen
A1 C. Amos
A1 M. Henley
A1 B. Kramer
A1 on behalf of the INTENSITY study investigators
YR 2011
UL http://erj.ersjournals.com/content/early/2011/05/26/09031936.00191810.abstract
AB Two once-daily (od) inhaled bronchodilators are available for the treatment of COPD: the β2-agonist indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents, and assessed their safety and tolerability.Patients with moderate-to-severe COPD were randomized to treatment with indacaterol 150 μg od (n=797) or tiotropium 18 μg od (n=801) for 12 weeks.After 12 weeks, the two treatments had similar overall effects on “trough” (24 h post-dose) FEV1. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.01 vs 1.43; p<0.001) and St George’s Respiratory Questionnaire (SGRQ) total score (least squares means 37.1 vs 39.2; p<0.001; raw mean change from baseline –5.1 vs –3.0), and were significantly more likely to achieve clinically relevant improvements in these end-points (odds ratios for indacaterol vs tiotropium of 1.49 for TDI and 1.43 for SGRQ, both p<0.001). Adverse events were recorded for 39.7% and 37.2% of patients in the indacaterol and tiotropium treatment groups, respectively; the most frequent adverse events were COPD worsening, cough and nasopharyngitis.Both bronchodilators demonstrated spirometric efficacy. The two treatments were well tolerated with similar adverse event profiles. Compared with tiotropium, indacaterol provided significantly greater improvements in clinical outcomes.ClinicalTrials.gov identifier: NCT00900731