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Table 1 Patient demographics and baseline characteristics

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

Characteristic UMEC/VI (N = 812) UMEC (N = 804) SAL (N = 809) Total (N = 2425)
Age, years, mean (SD) 64.6 (8.4) 64.9 (8.5) 64.4 (8.5) 64.6 (8.5)
Female, n (%) 319 (39) 327 (41) 342 (42) 988 (41)
Race, n (%)
 White 767 (94) 764 (95) 766 (95) 2297 (95)
 Black/African American 24 (3) 23 (3) 25 (3) 72 (3)
 American Indian/Alaska Native 13 (2) 12 (1) 12 (1) 37 (2)
 Asian 5 (< 1) 1 (< 1) 1 (< 1) 7 (< 1)
 Multiplea 3 (1) 4 (< 1) 5 (< 1) 12 (< 1)
Current smoker at screening, n (%) 394 (49) 396 (49) 413 (51) 1203 (50)
Smoking pack-years, mean (SD) 49.4 (27.7) 47.6 (25.9) 48.1 (25.8) 48.4 (26.5)
Use of LABD during run-in, n (%)b 531 (65) 521 (65) 524 (65) 1576 (65)
 LAMA 399 (49) 392 (49) 403 (50) 1194 (49)
 LABA 130 (16) 142 (18) 132 (16) 404 (17)
No maintenance medication during run-in, n (%) 250 (31) 250 (31) 249 (31) 749 (31)
Moderate COPD exacerbation history in prior yearc, n (%) 123 (15) 124 (15) 146 (18) 393 (16)
Duration of COPD, years, mean (SD) 8.8 (6.9) 7.8 (6.0) 8.3 (6.7) 8.3 (6.6)
Post-salbutamol FEV1, mL, mean (SD) 1577 (506) 1609 (503) 1600 (523) 1595 (511)
Post-salbutamol % predicted FEV1, mean (SD) 54.9 (12.8) 55.9 (12.6) 55.6 (12.8) 55.4 (12.7)
Post-salbutamol FEV1/FVC, mean (SD) 0.51 (0.10) 0.52 (0.10) 0.52 (0.10) 0.52 (0.10)
% reversibility to salbutamol, mean (SD) 10.4 (12.8) 10.2 (13.3) 10.7 (13.3) 10.5 (13.1)
GOLD spirometric graded, n (%)
 2 518 (64) 529 (66) 522 (65) 1569 (65)
 3 294 (36) 271 (34) 286 (35) 851 (35)
Baseline FEV1, mL, mean (SD) 1474 (513) 1503 (505) 1495 (533) 1491 (517)
BDI score, mean (SD) 7.0 (1.8) 7.0 (1.9) 7.1 (1.8) 7.01 (1.9)
Baseline E-RS total score 10.7 (5.6) 10.7 (5.8) 10.4 (5.7) 10.6 (5.7)
Baseline SGRQ score, mean (SD) 44.5 (16.1) 45.0 (16.1) 44.6 (16.3) 44.7 (16.2)
Baseline CAT score, mean (SD) 19.1 (5.9) 19.3 (6.2) 19.3 (6.3) 19.2 (6.1)
Baseline rescue salbutamol, puffs/day, mean (SD) 2.2 (2.6) 2.1 (2.3) 2.2 (2.5) 2.2 (2.5)
Any cardiac comorbiditiese, n (%) 111 (14) 136 (17) 117 (14) 364 (15)
Any vascular comorbiditiesf, n (%) 444 (55) 434 (54) 448 (55) 1326 (55)
  1. aIncludes American Indian/Alaska Native and White, Black/African American and White, Native Hawaiian/Other Pacific Islander and White; bpatients could be counted for both LAMA and LABA; cnumber of exacerbations requiring oral or systemic corticosteroids and/or antibiotics (moderate) in 12 months prior to screening (patients with > 1 moderate exacerbation or with a severe exacerbation [requiring hospitalisation] were excluded); dan additional 4 (< 1%) patients with GOLD grade 1 were randomised (UMEC n = 3; SAL n = 1); eincludes coronary artery disease, arrhythmia, congestive heart failure, and myocardial infarction; fincludes hypertension and cerebrovascular accident
  2. BDI Baseline dyspnoea index, CAT COPD Assessment Test, COPD Chronic obstructive pulmonary disease, E-RS Evaluating Respiratory Symptoms, FEV1 Forced expiratory volume in 1 s, FVC Forced vital capacity, GOLD Global Initiative for Chronic Obstructive Lung Disease, LABA Long-acting β2-agonist, LABD Long-acting bronchodilator, LAMA Long-acting muscarinic antagonists, SAL Salmeterol, SD Standard deviation, SGRQ St George’s Respiratory Questionnaire, UMEC Umeclidinium, VI Vilanterol