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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
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Respiratory Research

ISSN: 1465-993X

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