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Table 4 Results for symptomatic endpoints and health outcome measures (ITT population)

From: Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial

Endpoint UMEC/VI 62.5/25 mcg (N = 358) FP/SAL 500/50 mcg (N = 358)
Rescue salbutamol use
Mean number of puffs/day, weeks 1–12
n 334 349
LS mean (SE) 1.3 (0.08) 1.4 (0.08)
LS mean (SE) change from baseline −1.3 (0.08) −1.2 (0.08)
Treatment difference (95 % CI) −0.1 (−0.3–0.1)
p = 0.559
Percent rescue-free days during 12 weeks, change from baseline
n 334 349
Mean (SD), (%) 24.5 (36.38) 23.5 (36.95)
TDI focal score
n a 344 351
Day 28
n 343 350
LS mean (SE) 1.7 (0.13) 1.6 (0.13)
Treatment difference (95 % CI) 0.2 (−0.2–0.5)
p = 0.369
Day 56
n 336 343
LS mean (SE) 2.0 (0.12) 1.7 (0.12)
Treatment difference (95 % CI) 0.3 (0.0–0.6)
p = 0.078
Day 84
n 334 338
LS mean (SE) 2.0 (0.14) 2.1 (0.13)
Treatment difference (95 % CI) −0.1 (−0.4–0.3)
p = 0.702
SGRQ Total score, change from baseline
n a 339 349
Day 28
n 337 347
LS mean (SE) 41.25 (0.552) 40.03 (0.544)
LS mean change (SE) −3.83 (0.552) −5.05 (0.544)
Treatment difference (95 % CI) 1.22 (−0.30–2.75)
p = 0.116
Day 84
n 329 336
LS mean (SE) 39.98 (0.626) 39.44 (0.619)
LS mean change (SE) −5.10 (0.626) −5.64 (0.619)
Treatment difference (95 % CI) 0.53 (−1.20–2.26)
p = 0.545
EQ-5D utility score on Day 84, change from baseline
n 335 341
Mean (SD) 0.03 (0.189) 0.03 (0.203)
CAT score on Day 84, change from baseline
n 335 341
Mean (SD) −2.21 (6.054) −2.35 (6.432)
  1. CAT COPD Assessment Test, CI confidence interval, EQ-5D EuroQoL-5D, FP/SAL fluticasone propionate/salmeterol, ITT intent-to-treat, LS least squares, SE standard error, SD standard deviation, SGRQ St George’s Respiratory Questionnaire, TDI Transition Dyspnea Index, UMEC umeclidinium, VI vilanterol
  2. aNumber of patients with analysis data for one or more time points