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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.