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Table 1 Patient demographics (integrated ITT population)

From: Impact of prior and concurrent medication on exacerbation risk with long-acting bronchodilators in chronic obstructive pulmonary disease: a post hoc analysis

  Total
(N = 3021)
UMEC/VI
(n = 816)
UMEC
(n = 825)
VI
(n = 825)
PBO
(n = 555)
Age, years, mean (SD) 63.0 (8.7) 63.3 (8.4) 63.5 (8.8) 62.7 (8.7) 62.2 (8.8)
Male, n (%) 2057 (68) 569 (70) 568 (69) 550 (67) 370 (67)
BMI, kg/m2, mean (SD) 26.7 (5.8) 26.9 (5.6) 26.4 (5.7) 26.9 (6.0) 26.7 (6.0)
Current smoker, n (%) 1528 (51) 403 (49) 423 (51) 409 (50) 293 (53)
Smoking pack yearsa, mean (SD) 45.1 (24.8) 45.9 (25.7) 45.4 (25.3) 43.8 (23.2) 45.4 (25.3)
Pre-bronchodilator FEV1, mL, mean (SD)b 1258 (486) 1272 (503) 1254 (484) 1264 (490) 1234 (460)
Post-bronchodilator % predicted FEV1, mean (SD)c 47.8 (12.9) 47.8 (12.9) 47.8 (12.9) 48.4 (13.0) 47.1 (12.6)
GOLD stage III-IV, FEV1 < 50% predicted, n (%)c 1605 (53) 435 (54) 438 (53) 418 (51) 314 (57)
Exacerbation history, n (%)d
  ≥ 1 moderate exacerbatione 780 (26) 210 (26) 211 (26) 214 (26) 145 (26)
  ≥ 1 severe exacerbationf 302 (10) 72 (9) 82 (10) 93 (11) 55 (10)
Baseline mMRC dyspnea score, mean (SD) 2.4 (0.5) 2.4 (0.5) 2.4 (0.6) 2.3 (0.6) 2.4 (0.5)
Baseline albuterol use puffs/day, mean (SD)g,h 5.1 (5.4) 4.8 (5.1) 5.1 (5.4) 5.2 (5.4) 5.3 (5.9)
Maintenance-naïve, n (%)i
 Yes 984 (33) 285 (35) 245 (30) 272 (33) 182 (33)
 No 2037 (67) 531 (65) 580 (70) 553 (67) 373 (67)
ICS-free, n (%)
 Yes 1543 (51) 428 (52) 413 (50) 422 (51) 280 (50)
 No 1478 (49) 388 (48) 412 (50) 403 (49) 275 (50)
Baseline albuterol use, n (%)g,j
 High 1490 (50) 386 (48) 405 (50) 411 (51) 288 (53)
 Low 1488 (50) 420 (52) 408 (50) 401 (49) 259 (47)
  1. aSmoking pack years = (number of cigarettes smoked per day/20) x number of years smoked. bTotal: n = 3015; UMEC/VI: n = 815; UMEC: n = 824; VI: n = 822; PBO: n = 554. cTotal: n = 3012; UMEC/VI: n = 813; UMEC: n = 823; VI: n = 822; PBO: n = 554. dNumber of COPD exacerbations reported in the 12-months prior to screening. eRequired oral/systemic corticosteroids and/or antibiotics. fRequired hospitalization. gTotal: n = 2978; UMEC/VI: n = 806; UMEC: n = 813; VI: n = 812; PBO: n = 547. hBaseline rescue medication use was calculated for patients with non-missing values for at least half the days within the baseline period. iPrior to run-in. jMean puffs/day at baseline ≥ 3.60 (high) or < 3.60 (low); 3.60 is the median value of puffs of rescue medication per day at baseline across all treatment groups
  2. BMI body mass index, COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, GOLD Global initiative for chronic Obstructive Lung Disease, ICS inhaled corticosteroid, ITT intent-to-treat, mMRC modified medical research council, PBO placebo, SD standard deviation, UMEC umeclidinium, VI vilanterol