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Table 2 Dose–response relationship for glycopyrronium bromide treatment regimens: model-averaged analysis of trough FEV 1 , FEV 1 AUC 0-24h , FEV 1 AUC 0-12h , FEV 1 AUC 0-4h , and FEV 1 AUC 12-24h at steady state

From: A novel model-based approach for dose determination of glycopyrronium bromide in COPD

 

Glycopyrronium bromide dose

12.5 μg OD

25 μg OD

12.5 μg BID

50 μg OD

25 μg BID

100 μg OD

50 μg BID

Trough FEV 1 at steady state

       

Absolute increase over placebo (L), (SE)

0.051 (0.019)

0.079 (0.020)

0.115 (0.021)

0.109 (0.020)

0.141 (0.020)

0.137 (0.019)

0.160 (0.020)

90% CI

0.032, 0.081

0.054, 0.108

0.082, 0.142

0.083, 0.135

0.112, 0.163

0.111, 0.160

0.135, 0.181

% of projected maximum effect of any glycopyrronium bromide dose* (SE)

27 (11)

42 (12)

62 (14)

59 (12)

76 (13)

73 (12)

85 (11)

90% CI

16, 44

27, 61

37, 82

38, 76

49, 90

49, 87

60, 95

FEV 1 AUC 0-24h at steady state

       

Absolute increase over placebo (L), (SE)

0.058 (0.012)

0.089 (0.014)

0.098 (0.015)

0.123 (0.014)

0.131 (0.014)

0.152 (0.012)

0.158 (0.012)

90% CI

0.039, 0.079

0.066, 0.113

0.071, 0.122

0.099, 0.145

0.106, 0.152

0.131, 0.171

0.138, 0.176

% of projected maximum effect of any glycopyrronium bromide dose* (SE)

29 (7)

45 (8)

49 (9)

62 (8)

66 (8)

76 (6)

79 (6)

90% CI

19, 42

32, 59

34, 64

48, 74

51, 78

65, 85

68, 88

FEV 1 AUC 0-12h at steady state

       

Absolute increase over placebo (L), (SE)

0.085 (0.015)

0.121 (0.016)

0.104 (0.016)

0.152 (0.014)

0.139 (0.015)

0.176 (0.012)

0.166 (0.013)

90% CI

0.061, 0.111

0.094, 0.146

0.078, 0.130

0.128, 0.174

0.113, 0.162

0.155, 0.195

0.144, 0.186

% of projected maximum effect of any glycopyrronium bromide dose* (SE)

41 (8)

58 (8)

51 (8)

74 (6)

67 (7)

85 (4)

80 (5)

90% CI

29, 55

45, 71

37, 64

62, 83

54, 78

76, 91

70, 88

FEV 1 AUC 0-4h at steady state

       

Absolute increase over placebo (L), (SE)

0.105 (0.016)

0.138 (0.015)

0.122 (0.016)

0.165 (0.013)

0.153 (0.014)

0.183 (0.012)

0.175 (0.012)

90% CI

0.080, 0.132

0.114, 0.162

0.096, 0.148

0.143, 0.185

0.129, 0.174

0.163, 0.203

0.154, 0.195

% of projected maximum effect of any glycopyrronium bromide dose* (SE)

51 (8)

67 (7)

59 (8)

80 (6)

74 (7)

88 (5)

84 (6)

90% CI

39, 64

54, 78

46, 72

67, 87

61, 83

78, 93

73, 91

FEV 1 AUC 12-24h at steady state

       

Absolute increase over placebo (L), (SE)

0.051 (0.025)

0.079 (0.026)

0.112 (0.027)

0.111 (0.026)

0.141 (0.026)

0.141 (0.027)

0.163 (0.028)

90% CI

0.033, 0.080

0.056, 0.108

0.080, 0.139

0.086, 0.137

0.112, 0.163

0.116, 0.163

0.138, 0.184

% of projected maximum effect of any glycopyrronium bromide dose* (SE)

26 (11)

40 (12)

57 (14)

56 (13)

71 (14)

71 (13)

82 (13)

90% CI

16, 43

24, 60

31, 78

33, 75

42, 88

43, 86

51, 94

  1. *100 x (effect of this dosage/maximum theoretical effect predicted by model).
  2. OD: once daily; BID: twice daily; SE: standard error; CI: confidence interval; FEV1: forced expiratory volume in one second; AUC: area under the curve.
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BMC Pulmonary Medicine

ISSN: 1471-2466

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