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Table 3 Peak FVC and FVC AUC outcomes (safety population)

From: Abediterol, a novel long-acting β2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD

FVC variable (L)

Comparison

LS mean differences in changes from baseline

Abediterol 0.625 μg (N = 67)

Abediterol 2.5 μg (N = 66)

Abediterol 5 μg (N = 66)

Abediterol 10 μg (N = 67)

LS mean

95 % CI

p- value

LS mean

95 % CI

p-value

LS mean

95 % CI

p-value

LS mean

95 % CI

p-value

Normalised AUC0-12 at Day 1

vs placebo

0.227

0.169, 0.284

<0.0001

0.280

0.222, 0.337

<0.0001

0.301

0.243, 0.358

<0.0001

0.347

0.289, 0.405

<0.0001

vs indacaterol

0.010

−0.047, 0.068

0.7258

0.063

0.05, 0.121

0.0323

0.084

0.027, 0.142

0.0044

0.130

0.072, 0.188

<0.0001

Normalised AUC12-24 at Day 1

vs placebo

0.182

0.114, 0.249

<0.0001

0.308

0.201, 0.376

<0.0001

0.352

0.285, 0.420

<0.0001

0.386

0.319, 0.454

<0.0001

vs indacaterol

−0.026

−0.094, 0.042

0.4471

0.100

0.031, 0.166

0.0045

0.144

0.076, 0.212

<0.0001

0.178

0.110, 0.247

<0.0001

Normalised AUC0-24 at Day 1

vs placebo

0.208

0.153, 0.263

<0.0001

0.294

0.239, 0.349

<0.0001

0.332

0.276, 0.387

<0.0001

0.369

0.313, 0.424

<0.0001

vs indacaterol

−0.007

−0.063, 0.048

0.7996

0.079

0.023, 0.135

0.0058

0.117

0.061, 0.172

<0.0001

0.154

0.098, 0.209

<0.0001

Peak FVC at Day 1

vs placebo

0.152

0.035, 0.270

0.0110

0.191

0.074, 0.309

0.0015

0.201

0.083, 0.318

0.0009

0.244

0.127, 0.361

<0.0001

vs indacaterol

0.013

−0.104, 0.131

0.8219

0.052

−0.065, 0.170

0.3829

0.062

−0.056, 0.179

0.3024

0.105

−0.012, 0.222

0.0795

  1. Analyses were performed on the ITT population. For both placebo and indacaterol, N= 68
  2. LS mean differences and p-values obtained from an ANCOVA model for crossover designs with change from baseline in FVC variable as response, sequence, treatment group and period as fixed effect factors, patient within sequence as a random effect and the corresponding baseline value at each period as a covariate
  3. ANCOVA, analysis of covariance; AUC 0-12 area under the curve over the 12 h period immediately after morning IMP administration, AUC 12-24 area under the curve over the 12 h nighttime period immediately after morning IMP administration, AUC 0-24 area under the curve over the 24 h period immediately after morning IMP administration, CI confidence interval, FVC forced vital capacity, IMP investigational medicinal product, ITT intent-to-treat, LS least squares, N ITT population size of treatment group