PT  - JOURNAL ARTICLE
AU  - R. Buhl
AU  - L.J. Dunn
AU  - C. Disdier
AU  - C. Lassen
AU  - C. Amos
AU  - M. Henley
AU  - B. Kramer
AU  - on behalf of the INTENSITY study investigators
TI  - Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD
AID  - 10.1183/09031936.00191810
DP  - 2011 May 26
TA  - European Respiratory Journal
PG  - erj01918-2010
4099  - http://erj.ersjournals.com/content/early/2011/05/26/09031936.00191810.short
4100  - http://erj.ersjournals.com/content/early/2011/05/26/09031936.00191810.full
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