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Table 3 TDI responders/deteriorators at Week 24

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 = 607) Aclidinium 400 μg (n = 596) Formoterol 12 μg (n = 596) Placebo (n = 384)
Patients with ≥1 unit improvement in TDI, % 61.9 55.7 57.0 40.3
 OR vs placebo 2.8*** 2.1*** 2.2*** -
 OR vs aclidinium 1.3 - - -
 OR vs formoterol 1.3 - - -
Patients with ≤1 unit worsening in TDI, % 7.8 9.3 10.9 15.8
 OR vs placebo 0.4*** 0.6** 0.7 -
 OR vs aclidinium 0.8 - - -
 OR vs formoterol 0.7 - - -
  1. Data are for the pooled ITT population; MCID for TDI is ≥1 unit
  2. COPD chronic obstructive pulmonary disease, FDC aclidinium/formoterol fixed-dose combination, ITT intent-to-treat, OR odds ratio, TDI Transition Dyspnoea Index
  3. *** p < 0.001, ** p < 0.01 vs placebo