Skip to main content

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
Back to article page

Respiratory Research

ISSN: 1465-993X

Contact us