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Table 2 Change from baseline in pulmonary function parameters (L): intention-to-treat population

From: A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting β2-adrenergic agonist, in asthma; a Phase II, randomized study

 

Placebo N = 59

Salbutamol 400 μg N = 58

Abediterol 0.313 μg N = 60

Abediterol 0.625 μg N = 60

Abediterol 1.25 μg N = 60

Abediterol 2.5 μg N = 61

Peak FEV1

0.202 (0.045)

0.555**** (0.045)

0.477****†† (0.045)

0.524**** (0.045)

0.573**** (0.045)

0.608**** (0.045)

Trough FEV1 a

-0.054 (0.039)

-0.076 (0.039)

0.166****†††† (0.039)

0.205****†††† (0.039)

0.278****†††† (0.039)

0.346****†††† (0.039)

Normalized FEV1 AUC0–6

0.088 (0.039)

0.347**** (0.039)

0.354**** (0.038)

0.403**** (0.038)

0.461****†††† (0.038)

0.496****†††† (0.038)

Normalized FEV1 AUC0–12

0.063 (0.040)

0.219**** (0.040)

0.348****†††† (0.039)

0.393****†††† (0.039)

0.455****†††† (0.039)

0.496****†††† (0.040)

Normalized FEV1 AUC0–24

0.007 (0.039)

0.100** (0.039)

0.282****†††† (0.039)

0.321****†††† (0.038)

0.390****†††† (0.038)

0.446****†††† (0.039)

Peak FVC

0.222 (0.034)

0.361**** (0.034)

0.317** (0.034)

0.329*** (0.034)

0.361**** (0.034)

0.380**** (0.034)

Trough FVCa

-0.028 (0.035)

-0.065 (0.035)

0.094**†††† (0.035)

0.050*†† (0.035)

0.111***†††† (0.035)

0.120***†††† (0.035)

  1. Data are least squares means (standard error).
  2. atrough values are the mean of the 23 and 24 h post-dose measurements.
  3. *p < 0.05, **p < 0.01, ***p < 0.001, ****p < 0.0001 versus placebo; p < 0.05, ††p < 0.01, ††††p < 0.0001 versus salbutamol 400 μg (analysis of covariance).
  4. AUC, area under the FEV1 curve; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity.