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Table 2 Adjusted mean FEV 1 AUC 0–12 , AUC 12–24 , and AUC 0–24 responses (L) compared to placebo after 6 weeks

From: The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2–4 COPD: results from two 6-week crossover studies

 

Treatment

Adjustedamean (95% CI) difference from placebo at 6 weeks

FEV 1 AUC 0–12

n

Adjusted mean (SE)

Mean (SE)

P value

95% CI

Study 1222.24

     

  Placebo

93

−0.060 (0.020)

   

  Olodaterol 5 μg QD

92

0.088 (0.021)

0.148 (0.018)

< .0001

0.113, 0.183

  Olodaterol 10 μg QD

91

0.088 (0.021)

0.148 (0.018)

< .0001

0.113, 0.183

  Formoterol 12 μg BID

90

0.081 (0.021)

0.141 (0.018)

< .0001

0.106, 0.177

Study 1222.25

     

  Placebo

91

−0.022 (0.024)

   

  Olodaterol 5 μg QD

92

0.150 (0.024)

0.172 (0.017)

< .0001

0.139, 0.205

  Olodaterol 10 μg QD

90

0.152 (0.024)

0.174 (0.017)

< .0001

0.140, 0.208

  Formoterol 12 μg BID

90

0.136 (0.024)

0.158 (0.017)

< .0001

0.124, 0.191

FEV 1 AUC 12–24

     

Study 1222.24

     

  Placebo

93

−0.123 (0.021)

   

  Olodaterol 5 μg QD

92

−0.014 (0.022)

0.109 (0.019)

< .0001

0.073, 0.146

  Olodaterol 10 μg QD

91

0.004 (0.022)

0.127 (0.019)

< .0001

0.091, 0.164

  Formoterol 12 μg BID

90

0.049 (0.022)

0.172 (0.019)

< .0001

0.135, 0.209

Study 1222.25

     

Placebo

91

−0.048 (0.025)

   

  Olodaterol 5 μg QD

92

0.069 (0.025)

0.118 (0.018)

< .0001

0.082, 0.154

  Olodaterol 10 μg QD

90

0.072 (0.025)

0.120 (0.018)

< .0001

0.084, 0.157

  Formoterol 12 μg BID

90

0.107 (0.025)

0.155 (0.018)

< .0001

0.119, 0.191

FEV 1 AUC 0–24

     

Study 1222.24

     

  Placebo

93

−0.092 (0.020)

   

  Olodaterol 5 μg QD

92

0.037 (0.021)

0.128 (0.017)

< .0001

0.094, 0.163

  Olodaterol 10 μg QD

91

0.046 (0.021)

0.137 (0.017)

< .0001

0.103, 0.172

  Formoterol 12 μg BID

90

0.065 (0.021)

0.156 (0.018)

< .0001

0.122, 0.191

Study 1222.25

     

  Placebo

91

−0.035 (0.024)

   

  Olodaterol 5 μg QD

92

0.110 (0.024)

0.145 (0.016)

< .0001

0.114, 0.176

  Olodaterol 10 μg QD

90

0.112 (0.024)

0.147 (0.016)

< .0001

0.116, 0.179

  Formoterol 12 μg BID

90

0.121 (0.024)

0.156 (0.016)

< .0001

0.125, 0.187

  1. AUC0–12 = area under the curve from 0 to 12 h; AUC0–24 = area under the curve from 0 to 24 h; AUC12–24 = area under the curve from 12 to 24 h; BID = twice daily; FEV1 = forced expiratory volume in 1 sec; SE = standard error.
  2. aBased on a mixed effects repeated measures model. The model includes treatment and period as fixed effects and center and patient within center as random effects, along with compound symmetry as a covariance structure for within−patient variation.
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