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Table 1 Patient demographics and clinical characteristics (ITT population)

From: Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study

Characteristic

FF/UMEC/VI 100/62.5/25 μg

FF/VI 100/25 μg + UMEC 62.5 μg

Total

(N = 527)

(N = 528)

(N = 1055)

Age (years), mean (SD)

66.7 (8.5)

65.9 (8.8)

66.3 (8.6)

Female, n (%)

136 (26)

134 (25)

270 (26)

Current smoker at screening, n (%)

209 (40)

192 (36)

401 (38)

Smoking pack-years, mean (SD)

43.4 (23.9)

44.2 (25.2)

43.8 (24.6)

Current cardiovascular risk factors, n (%)

379 (72)

367 (70)

746 (71)

Number of exacerbations in previous 12 months, n (%)a

 1 moderate/severe

236 (45)

227 (43)

463 (44)

  ≥ 2 moderate/severe

291 (55)

301 (57)

592 (56)

  ≥ 2 moderate or ≥1 severe

352 (67)

360 (68)

712 (67)

History of pneumonia, n (%)

86 (16)

100 (19)

186 (18)

Screening lung function, mean (SD)

n = 515

n = 512

n = 1027

 Post-bronchodilator FEV1, mL

1247 (465)

1297 (471)

1272 (469)

 Post-bronchodilator FVC, mL

2879 (885)

2896 (849)

2887 (867)

 Post-bronchodilator FEV1/FVC ratio

0.440 (0.116)

0.455 (0.119)

0.447 (0.118)

 Post-bronchodilator percent predicted FEV1

44.5 (14.5)

45.5 (14.1)

45.0 (14.3)

 Percent reversibility

9.02 (11.22)

8.87 (10.15)b

8.95 (10.69)

Number of long-acting bronchodilators per day during the run-in, n (%)

 0/1

225 (43)

226 (43)

451 (43)

 2

302 (57)

302 (57)

604 (57)

Concomitant COPD medications taken at screening, n (%)

 Single-inhaler maintenance bronchodilator

40 (8)

42 (8)

82 (8)

 LAMA

32 (6)

35 (7)

67 (6)

 LABA

8 (2)

7 (1)

15 (1)

Combination therapy

448 (85)

443 (84)

891 (84)

 ICS + LABA+LAMA

198 (38)

193 (37)

391 (37)

 ICS + LABA

144 (27)

137 (26)

281 (27)

 LABA+LAMA

62 (12)

76 (14)

138 (13)

 ICS + LABA+LAMA+ xanthine

29 (6)

25 (5)

54 (5)

 ICS + LAMA

7 (1)

9 (2)

16 (2)

 LABA+LAMA+xanthine

8 (2)

3 (< 1)

11 (1)

COPD severity at screening

GOLD grade, n (%)

n = 515

n = 512

n = 1027

 1 (mild)

0

1 (< 1)

1 (< 1)

 2 (moderate)

174 (34)

189 (37)

363 (35)

 3 (severe)

251 (49)

253 (49)

504 (49)

 4 (very severe)

90 (17)

69 (13)

159 (15)

Reversible, n (%)c

n = 515

n = 511

n = 1026

 Yes

73 (14)

74 (14)

147 (14)

GOLD grade/exacerbation history, n (%)a

n = 514

n = 512

n = 1026

 Grade 1/2 with ≥2 moderate or ≥1 severe

173 (34)

190 (37)

363 (35)

 Grade 3/4 with < 2 moderate and no severe

171 (33)

164 (32)

335 (33)

 Grade 3/4 with ≥2 moderate or ≥1 severe

170 (33)

158 (31)

328 (32)

CAT score, mean (SD)

19.6 (5.8)

20.1 (6.1)

19.9 (6.0)

  1. CAT COPD Assessment Test™, COPD chronic obstructive pulmonary disease, FEV 1 forced expiratory volume in 1 s, FF fluticasone furoate, FVC forced vital capacity, GOLD Global Initiative for Chronic Obstructive Lung Disease, ICS inhaled corticosteroid, ITT intent-to-treat, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist, SD standard deviation, UMEC umeclidinium, VI vilanterol
  2. aModerate exacerbations were defined as exacerbations requiring oral/systemic corticosteroids and/or antibiotics (not involving hospitalization). Severe exacerbations were defined as exacerbations that required in-patient hospitalization
  3. bFF/VI + UMEC, n = 511
  4. cReversible was an increase in FEV1 of ≥12% and ≥200 mL following administration of salbutamol. Not reversible was an increase in FEV1 of < 200 or ≥200 mL increase that is < 12% of the pre-salbutamol FEV1
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Respiratory Research

ISSN: 1465-993X

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