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Table 2 LS mean change from baseline and proportion of responders for patient reported-outcomes

From: Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial

  UMEC/VI (N = 812) UMEC (N = 804) SAL (N = 809)
Symptom severity outcomes
SAC-TDI focal score at Week 24
  LS mean (95% CI) 1.68 (1.46, 1.89) 1.30 (1.08, 1.53) 1.22 (1.00, 1.44)
  UMEC/VI vs comparator mean difference (95% CI) 0.37 (0.06, 0.68)
p = 0.018
0.45 (0.15, 0.76)
p = 0.004
  SAC-TDI respondersa, n/N (%) 403/806 (50) 332/799 (42) 330/807 (41)
  UMEC/VI vs comparator odds ratio (95% CI) 1.43 (1.17, 1.75); p < 0.001 1.48 (1.21, 1.81); p < 0.001
E-RS total score at Weeks 21–24
  LS mean CFB (95% CI) −  1.52 (− 1.81, − 1.23) − 0.99 (− 1.29, − 0.69) − 0.69 (− 0.98, − 0.39)
  UMEC/VI vs comparator mean difference (95% CI) − 0.53 (− 0.95, − 0.11)
p = 0.013
− 0.83 (− 1.25, − 0.42)
p < 0.001
  E-RS respondersb, n/N (%) 290/809 (36) 219/800 (27) 217/808 (27)
  UMEC/VI vs comparator odds ratio (95% CI) 1.52 (1.22, 1.89); p < 0.001 1.53 (1.23, 1.90); p < 0.001
Rescue medication use at Weeks 1–24
 Mean inhalations/day
  LS mean CFB (95% CI) − 0.61 (− 0.71, − 0.50) − 0.28 (− 0.38, − 0.17) − 0.32 (− 0.43, − 0.22)
  UMEC/VI vs comparator mean difference (95% CI) − 0.33 (− 0.48, − 0.18)
p < 0.001
− 0.28 (− 0.43, − 0.14)
p < 0.001
 % rescue medication-free days
  LS mean CFB (95% CI) 12.39 (10.28, 14.50) 6.55 (4.42, 8.68) 7.68 (5.55, 9.80)
  UMEC/VI vs comparator mean difference (95% CI) 5.84 (2.84, 8.84) p < 0.001 4.71 (1.72, 7.70) p = 0.002
Global assessment of disease severityc at Week 24
  UMEC/VI vs comparator ordered odds ratio for improvement in response category (95% CI) 1.38 (1.14, 1.67); p = 0.001 1.38 (1.14, 1.68); p < 0.001
Health status outcomes
SGRQ total score at Week 24
  LS mean CFB (95% CI) − 4.98 (− 5.89, − 4.07) − 5.23 (− 6.18, − 4.28) − 3.29 (− 4.22, − 2.36)
  UMEC/VI vs comparator mean difference (95% CI) 0.25 (− 1.07, 1.57)
p = 0.709
− 1.69 (− 2.99, − 0.39)
p = 0.011
  SGRQ respondersd, n/N (%) 366/811 (45) 329/802 (41) 291/809 (36)
  UMEC/VI vs comparator odds ratio (95% CI) 1.21 (0.99, 1.48); p = 0.063 1.49 (1.22, 1.83); p < 0.001
CAT score at Week 24
  LS mean CFB (95% CI) − 3.5 (− 3.9, − 3.1) − 3.4 (− 3.9, − 3.0) − 2.9 (− 3.4, − 2.5)
  UMEC/VI vs comparator mean difference (95% CI) 0.0 (− 0.6, 0.6)
p = 0.891
− 0.5 (− 1.1, 0.1)
p = 0.074
  CAT responderse, n/N (%) 447/812 (55) 385/804 (48) 406/809 (50)
  UMEC/VI vs comparator odds ratio (95% CI) 1.35 (1.11, 1.65); p = 0.003 1.23 (1.01, 1.50); p = 0.037
  1. aSAC-TDI responders were defined as a ≥ 1-unit improvement from baseline; bE-RS responders were defined as a reduction of ≥2 from baseline; coverall assessment of change in COPD severity was rated using a seven-point Likert scale (‘Much Better’, ‘Slightly Better’, ‘Better’, ‘No Change’, ‘Slightly Worse’, ‘Worse’, ‘Much Worse’). Ordered response ratios were reported as odds of better response category; dSGRQ responders were defined as a ≥ 4-point reduction from baseline; eCAT responders were defined as a ≥ 2-unit improvement from baseline
  2. CAT COPD Assessment Test, CFB Change from baseline, CI, COPD Chronic obstructive pulmonary disease; e-diary, electronic diary, E-RS Evaluating Respiratory Symptoms-COPD, LS Least squares, n/N number of responders/number of patients with analysable data, SAC-TDI Self-administered computerised Transition Dyspnoea Index, SAL Salmeterol, SGRQ St George’s Respiratory Questionnaire, UMEC Umeclidinium, VI Vilanterol