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)

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

	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)	-	-

Data are for the pooled ITT-exacerbations population
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
^* p < 0.05 vs placebo

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