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Table 5 0–12-hour and 12–24-hour weighted mean FEV 1 (L) on Day 7, (a) morning and (b) evening dose (mITT population)

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

a.

Morning dose:

 

UMEC QD

0–12-hour

Placebo

15.6 μg

31.25 μg

62.5 μg

125 μg

weighted mean FEV1(L)

N = 60

N = 60

N = 57

N = 59

N = 60

N

54

58

52

56

56

LS mean (SE)

1.353 (0.019)

1.467 (0.019)

1.478 (0.020)

1.481 (0.019)

1.526 (0.019)

LS mean change (SE)

−0.046 (0.019)

0.068 (0.019)

0.078 (0.020)

0.082 (0.019)

0.126 (0.019)

Difference from placebo

N/A

0.114

0.124

0.128

0.172

95% CI

N/A

(0.066, 0.161)

(0.075, 0.173)

(0.079, 0.177)

(0.124, 0.220)

p-value

N/A

<0.001

<0.001

<0.001

<0.001

Morning dose:

UMEC BID

Tiotropium QD

0–12-hour

15.6 μg

31.25 μg

18 μg

weighted mean FEV 1 (L)

N= 56

N= 58

N= 56

N

52

55

53

LS mean (SE)

1.483 (0.020)

1.483 (0.019)

1.530 (0.020)

LS mean change (SE)

0.084 (0.020)

0.084 (0.019)

0.130 (0.020)

Difference from placebo

0.130

0.130

0.176

95% CI

(0.081, 0.178)

(0.081, 0.178)

(0.128, 0.224)

p-value

<0.001

<0.001

<0.001

b.

Evening dose:

Placebo

UMEC QD

12–24-hour

15.6 μg

31.25 μg

62.5 μg

125 μg

weighted mean FEV 1 (L)

N= 60

N= 60

N= 57

N= 59

N= 60

n

54

56

52

54

56

LS mean (SE)

1.298 (0.020)

1.410 (0.020)

1.410 (0.020)

1.433 (0.020)

1.470 (0.020)

LS mean change (SE)

−0.103 (0.020)

0.010 (0.020)

0.010 (0.020)

0.032 (0.020)

0.069 (0.020)

Difference from placebo

N/A

0.112

0.112

0.135

0.172

95% CI

N/A

(0.064, 0.160)

(0.063, 0.162)

(0.085, 0.184)

(0.123, 0.221)

p-value

N/A

<0.001

<0.001

<0.001

<0.001

Evening dose:

UMEC BID

Tiotropium QD

12–24-hour

15.6 μg

31.25 μg

18 μg

weighted mean FEV 1 (L)

N= 56

N= 58

N= 56

n

52

55

53

LS mean (SE)

1.440 (0.020)

1.450 (0.020)

1.437 (0.020)

LS mean change (SE)

0.039 (0.020)

0.050 (0.020)

0.036 (0.020)

Difference from placebo

0.141

0.152

0.138

95% CI

(0.092, 0.191)

(0.103, 0.201)

(0.090, 0.187)

p-value

<0.001

<0.001

<0.001