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Table 4 Trough 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

Trough FEV1(L)

Placebo

UMEC QD

15.6 μg

31.25 μg

62.5 μg

125 μg

N = 60

N = 60

N = 57

N = 59

N = 60

N

60

59

56

59

60

LS mean (SE)

1.401 (0.019)

1.469 (0.019)

1.482 (0.020)

1.475 (0.019)

1.521 (0.019)

LS mean change (SE)

−0.014 (0.019)

0.054 (0.019)

0.067 (0.020)

0.060 (0.019)

0.106 (0.019)

Difference from placebo

N/A

0.068

0.081

0.074

0.120

95% CI

N/A

(0.018, 0.118)

(0.030, 0.131)

(0.024, 0.124)

(0.070, 0.170)

p-value

N/A

0.007

0.002

0.004

<0.001

Trough FEV 1 (L)

UMEC BID

Tiotropium QD

15.6 μg

31.25 μg

18 μg

N = 56

N = 58

N = 56

N

55

57

56

LS mean (SE)

1.484 (0.020)

1.500 (0.020)

1.493 (0.020)

LS mean change (SE)

0.069 (0.020)

0.085 (0.020)

0.078 (0.020)

Difference from placebo

0.083

0.099

0.092

95% CI

(0.032, 0.134)

(0.048, 0.149)

(0.041, 0.142)

p-value

0.001

<0.001

<0.001

  1. Analysis performed using a mixed model with covariates of period baseline, mean baseline, treatment and period as fixed effects and patient as a random effect; for each treatment period, baseline was defined as the mean of the values obtained 5 and 30 minutes pre-dose on Day 1 and trough FEV1 is calculated from the FEV1 values obtained 23 and 24 hours after the Day 6 morning dose.
  2. BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 second; LS, least square; mITT, modified intent-to-treat; N/A, 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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