Table 3– Trough forced expiratory volume in 1 s at week 12 in all patients (primary end-point; per-protocol population) and in patient subgroups of the intent-to-treat population
IndacaterolTiotropiumIndacaterol–tiotropium differencep-value for non-inferiorityp-value for superiority
All patients1.44±0.0101.43±0.0100.00 (-0.02–0.02)<0.0010.850
Patient subgroups
 Age yrs
  <651.44±0.0111.45±0.0110.00 (-0.03–0.02)<0.0010.774
  ≥651.44±0.0121.43±0.0120.01 (-0.02–0.04)<0.0010.420
 Sex
  Male1.44±0.0101.44±0.0100.00 (-0.02–0.02)<0.0010.987
  Female1.44±0.0151.43±0.0140.01 (-0.03–0.04)<0.0010.659
 Smoking status
  Ex-smoker1.45±0.0111.46±0.011-0.01 (-0.04–0.01)<0.0010.409
  Current smoker1.44±0.0121.42±0.0120.02 (-0.01–0.05)<0.0010.177
 COPD severity
  Moderate or less1.45±0.0111.42±0.0110.03 (0.01–0.05)<0.0010.013
  Severe or very severe1.42±0.0141.47±0.013-0.04 (-0.07– -0.01)0.2150.007
 ICS use
  No1.46±0.0121.44±0.0120.02 (-0.01–0.04)<0.0010.244
  Yes1.43±0.0111.44±0.011-0.01 (-0.03–0.02)<0.0010.495
 Reversibility to salbutamol
  ≤12%1.43±0.0121.42±0.0120.01 (-0.02–0.03)<0.0010.631
  >12%1.46±0.0131.46±0.0130.00 (-0.03–0.03)<0.0010.948
  • Data are presented as mean±se or mean (95% CI), unless otherwise stated. COPD: chronic obstructive pulmonary disease; ICS: inhaled corticosteroid.