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Table 3 Efficacy results

From: A randomized, controlled, repeat-dose study of batefenterol/fluticasone furoate compared with placebo in the treatment of COPD

 

BAT/FF 300/100

(n = 42)

Placebo

(n = 20)

Trough FEV1 at Day 42, La

n = 42

n = 20

 LS mean change (SE)

0.24 (0.03)

−0.02 (0.04)

 Difference vs. placebo (95% CI)

0.26 (0.17, 0.36)

Rescue medication use Weeks 1–6, number of occasions/dayb

n = 37

n = 16

 LS mean change (SE)

−0.50 (0.15)

−0.33 (0.24)

 Difference vs. placebo (95% CI)

−0.17 (− 0.75, 0.42)

CAT score at Day 42b

n = 35

n = 18

 LS mean change (SE)

−1.86 (0.78)

−0.11 (1.14)

 Difference vs. placebo (95% CI)

−1.75 (−4.54, 1.04)

SGRQ score at Day 42b

n = 34

n = 18

 LS mean change (SE)

−3.13 (1.79)

−1.48 (2.62)

 Difference vs. placebo (95% CI)

−1.65 (− 8.13, 4.84)

  1. aMMRM analysis; bANCOVA model
  2. ANCOVA analysis of covariance, BAT/FF 300/100 batefenterol/fluticasone furoate 300/100 μg, CAT COPD Assessment Test, CI confidence interval, FEV1 forced expiratory volume in 1 s, LS least squares, MMRM mixed models repeated measures, SE standard error, SGRQ St George’s Respiratory Questionnaire