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Table 3 0–24-hour weighted mean FEV 1 (L) on Day 7 (mITT population)

From: Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study

0–24-hour weighted mean FEV1(L)

Placebo N = 60

UMEC QD

15.6 μg

31.25 μg

62.5 μg

125 μg

N = 60

N = 57

N = 59

N = 60

N

54

56

51

54

56

LS mean (SE)

1.327 (0.018)

1.443 (0.018)

1.445 (0.019)

1.459 (0.018)

1.500 (0.018)

LS mean change (SE)

−0.074 (0.018)

0.043 (0.018)

0.045 (0.019)

0.059 (0.018)

0.100 (0.018)

Difference from placebo

NA

0.116

0.118

0.132

0.173

95% CI

NA

(0.072, 0.160)

(0.073, 0.163)

(0.087, 0.178)

(0.129, 0.217)

p-value

NA

<0.001

<0.001

<0.001

<0.001

0–24-hour

UMEC BID

Tiotropium

weighted mean FEV 1 (L)

15.6 μg

31.25 μg

QD 18 μg

N = 56

N = 58

N = 56

N

52

55

53

LS mean (SE)

1.462 (0.018)

1.469 (0.018)

1.484 (0.018)

LS mean change (SE)

0.062 (0.018)

0.068 (0.018)

0.084 (0.018)

Difference from placebo

0.136

0.142

0.157

95% CI

(0.091, 0.181)

(0.098, 0.186)

(0.113, 0.202)

p-value

<0.001

<0.001

<0.001

  1. Note: Analysis performed using a mixed model with covariates of trough mean baseline, trough period baseline, treatment and period as fixed effects and subject as a random effect.
  2. For each treatment period, baseline was defined as the mean of the values obtained 5 and 30 minutes predose on Day 1.
  3. BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 second; LS, least square; mITT, modified intent-to-treat; NA, not applicable; QD, once daily; SE, standard error; UMEC, umeclidinium bromide.
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BMC Pulmonary Medicine

ISSN: 1471-2466

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