TABLE 3

Changes in TDI score, SGRQ score and CAT score (intent-to-treat population)

UMECGLYCODifference or odds ratio UMEC versus GLYCO (95% CI)
Patients516518
TDI score
Day 28#Difference
  Patients with analysable data502497
  Change from baseline1.36±0.1161.31±0.1160.05 (−0.27, 0.38); p=0.743
Day 56#
  Patients with analysable data497492
  Change from baseline1.67±0.1171.48±0.1180.19 (−0.14, 0.51); p=0.261
Day 84#
  Patients with analysable data491486
  Change from baseline1.74±0.1161.66±0.1160.08 (−0.24, 0.40); p=0.636
TDI responders
Day 28Odds ratio
  Total patients515514
  Responders266 (52)260 (51)1.05 (0.82, 1.36); p=0.694
Day 56
  Total patients515515
  Responders289 (56)249 (48)1.44 (1.11, 1.88); p=0.007+
Day 84
  Total patients515515
  Responders280 (54)268 (52)1.12 (0.87, 1.46); p=0.379
SGRQ total score
Day 28#Difference
  Patients with analysable data491479
  Change from baseline−4.16±0.467−4.13±0.472−0.03 (−1.33, −1.28); p=0.970
Day 84#
  Patients with analysable data477466
  Change from baseline−4.75±0.545−4.11±0.551−0.64 (−2.17, 0.88); p=0.406
SGRQ responders
Day 28Odds ratio
  Total patients504497
  Responders218 (43)224 (45)0.94 (0.73, 1.22); p=0.660
Day 84
  Total patients508503
  Responders221 (44)230 (46)0.92 (0.72, 1.19); p=0.541
CAT score
Day 28#Difference
  Patients with analysable data503500
  Change from baseline−1.29±0.226−1.27±0.226−0.02 (−0.65, 0.61); p=0.949
Day 84#
  Patients with analysable data494488
  Change from baseline−1.70±0.254−1.19±0.256−0.51 (−1.22, 0.19); p=0.156
CAT responders
Day 28Odds Ratio
  Total patients516518
  Responders227 (44)251 (48)0.85 (0.66, 1.09); p=0.199
Day 84
  Total patients516518
  Responders237 (46)249 (48)0.94 (0.73, 1.21); p=0.630
  • Data are presented as n, least squares mean±se or n (%), unless otherwise stated. Differences and odd ratios are umeclidinium (UMEC) versus glycopyrronium (GLYCO). #: analysis performed using a mixed-model repeated measures with covariates of treatment, baseline dyspnoea index score or baseline St George's Respiratory Questionnaire (SGRQ) or chronic obstructive pulmonary disease assessment test (CAT) total score (scores recorded on day 1), centre group, 24H subset flag, day, day by baseline and day by treatment interactions. : analysis performed using a separate logistic regression model at each visit with covariates of treatment, baseline dyspnoea index score or SGRQ or CAT score at baseline, centre group and 24H subset flag. Transition dyspnoea index (TDI) response was defined as patients who had a ≥1 unit TDI focal score. SGRQ response was defined as an SGRQ total score of 4 units below baseline (scores recorded on day 1) or lower. CAT response within a patient was defined as a CAT score 2 units below baseline or lower. +: inference of statistical significance was drawn from p-values for treatment comparisons on these non-lung-function related endpoints and they were termed statistically significant if p<0.05. 24H: subset of patients who completed 24-h spirometry on day 1 and day 84.