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Table 4 Time to first COPD exacerbation based on HCRU and EXACT

From: Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT)

  FDC 400/12 μg (n = 720) Aclidinium 400 μg (n = 722) Formoterol 12 μg (n = 716)
Time to first HCRU exacerbation of any severity    
 HR vs placebo (95 % CI) 0.72 (0.53, 0.97)* 0.86 (0.64, 1.14) 0.94 (0.71, 1.25)
 HR vs aclidinium (95 % CI) 0.84 (0.63, 1.12) - -
 HR vs formoterol (95 % CI) 0.77 (0.58, 1.01) - -
Time to first HCRU exacerbation of moderate to severe severity    
 HR vs placebo (95 % CI) 0.70 (0.51, 0.96)* 0.84 (0.62, 1.14) 0.90 (0.67, 1.22)
 HR vs aclidinium (95 % CI) 0.83 (0.61, 1.13) - -
 HR vs formoterol (95 % CI) 0.77 (0.57, 1.05) - -
Time to first EXACT exacerbation of any severity    
 HR vs placebo (95 % CI) 0.79 (0.65, 0.95)* 0.92 (0.76, 1.10) 0.85 (0.71, 1.03)
 HR vs aclidinium (95 % CI) 0.86 (0.72, 1.03) - -
 HR vs formoterol (95 % CI) 0.92 (0.77, 1.10) - -
  1. Data are for the pooled ITT-exacerbations population
  2. CI confidence interval, COPD chronic obstructive pulmonary disease, EXACT EXAcerbations of Chronic obstructive pulmonary disease Tool, FDC aclidinium/formoterol fixed-dose combination, HCRU Healthcare Resource Utilisation, HR hazard ratio, ITT intent-to-treat
  3. * p < 0.05 vs placebo