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Table 1 Baseline patient demographics, lung function and clinical characteristics (ITT population)

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

  UMEC/VI 62.5/25 mcg (N = 358) FP/SAL 500/50 mcg (N = 358) Total (N = 716)
Age, mean ± SD, years 61.8 ± 7.94 61.4 ± 8.06 61.6 ± 8.00
Sex: male, n (%) 261 (73) 254 (71) 515 (72)
BMI, mean ± SD (range), kg/m2 27.69 ± 5.085 27.26 ± 5.018 27.47 ± 5.052
(16.9–45.8) (15.6–44.4) (15.6–45.8)
Race, n (%)    
White 358 (100) 358 (100) 716 (100)
Smoking history and status    
Current smoker, n (%) 204 (57) 217 (61) 421 (59)
Years smoked, mean ± SD (range) 37.8 ± 10.15 37.7 ± 10.27 37.8 ± 10.20
(7–67) (10–70) (7–70)
No. cigarettes/day, mean ± SD (range) 21.6 ± 8.18 20.8 ± 7.72 21.2 ± 7.96
(5–60) (7–80) (5–80)
Smoking pack years, mean ± SD (range) 40.7 ± 19.26 39.4 ± 19.09 40.1 ± 19.17
(10–125) (10–140) (10–140)
COPD history    
Duration of COPD, n (%), years    
  < 1 10 (3) 15 (4) 25 (3)
  ≥ 1 to <5 141 (39) 140 (39) 281 (39)
  ≥ 5 to <10 128 (36) 122 (34) 250 (35)
  ≥ 10 79 (22) 81 (23) 160 (22)
COPD type, n (%) a    
 Chronic bronchitis 279 (78) 287 (80) 566 (79)
 Emphysema 189 (53) 180 (50) 369 (52)
Screening lung function, mean (SD)    
Pre-salbutamol FEV1, L 1.423 (0.4573) 1.457 (0.4555) 1.440 (0.4564)
Post-salbutamol FEV1, L 1.550 (0.4488) 1.595 (0.4614) 1.572 (0.4554)
Pre-bronchodilator FEV1/FVC 47.7 (10.70) 48.2 (10.08) 47.9 (10.39)
Post-salbutamol FEV1/FVC 49.0 (10.69) 49.8 (10.19) 49.4 (10.45)
Post-salbutamol percent predicted FEV1, (%) 50.2 (10.85) 51.1 (10.50) 50.6 (10.68)
Percent reversibility to salbutamol, (%) 10.7 (12.64) 10.9 (12.63) 10.8 (12.63)
Reversibility to salbutamol, L 0.127 (0.159) 0.138 (0.154) 0.133 (0.157)
 Reversible to salbutamol, n (%) 100 (28) 108 (30) 208 (29)
GOLD stage (percent predicted FEV1), n (%)    
Stage B 193 (54) 201 (56) 394 (55)
Stage D 165 (46) 157 (44) 322 (45)
mMRC dyspnoea scale, mean (SD) 2.2 (0.41) 2.2 (0.42) 2.2 (0.41)
Rescue salbutamol use    
Puffs per day 2.9 (3.30)b 2.4 (2.38) -
Rescue-free days (%) 24.4 (35.01)b 28.3 (37.40) -
BDI focal score on Day 1 6.2 (1.78) 6.4 (1.58)c -
SGRQ Total score, mean (SD) 46.57 (16.523)d 44.02 (15.756)b -
EQ-5D utility score, mean (SD) 0.70 (0.213) 0.75 (0.191) -
CAT score, mean (SD) 18.48 (6.698) 17.20 (7.031) -
  1. BDI baseline Dyspnoea Index, BMI body mass index, CAT COPD Assessment Test, COPD chronic obstructive pulmonary disease, EQ-5D EuroQol-5D questionnaire, FP/SAL fluticasone propionate/salmeterol, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, GOLD Global initiative for chronic Obstructive Lung Disease, ITT intent-to-treat, mMRC modified Medical Research Council, SD standard deviation, SGRQ St. George’s Respiratory Questionnaire, UMEC umeclidinium, VI vilanterol
  2. aPatients could select chronic bronchitis, emphysema or both; bn = 354; cn = 356; dn = 353