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Table 1 Patient demographics and baseline characteristics by subgroups and overall (combined OTEMTO® 1 and 2; treated set)

From: Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO® studies

 

GOLD 2

GOLD 3

GOLD A

GOLD B

GOLD C

GOLD D

Naive: no

Naive: yes

ICS: no

ICS: yes

Overall

Patients, n

1042

570

486

483

250

400

943

678

1013

608

1621

Male, n (%)

609 (58.4)

374 (65.6)

298 (61.3)

271 (56.1)

167 (66.8)

250 (62.5)

574 (60.9)

413 (60.9)

632 (62.4)

355 (58.4)

987 (60.9)

Mean (SD) age, years

64.3 (8.7)

65.5 (7.9)

64.3 (8.1)

64.4 (9.0)

65.2 (8.6)

65.4 (7.9)

65.6 (8.2)

63.5 (8.6)

63.9 (8.4)

66.1 (8.3)

64.7 (8.4)

Smoking status, n (%)

           

 Ex-smoker

554 (53.2)

300 (52.6)

260 (53.5)

255 (52.8)

135 (54.0)

207 (51.8)

560 (59.4)

298 (44.0)

473 (46.7)

385 (63.3)

858 (52.9)

 Current smoker

488 (46.8)

270 (47.4)

226 (46.5)

228 (47.2)

115 (46.0)

193 (48.3)

383 (40.6)

380 (56.0)

540 (53.3)

223 (36.7)

763 (47.1)

Mean (SD) pre-bronchodilator

           

 FEV1, L

1.557 (0.460)

0.969 (0.262)

1.617 (0.469)

1.499 (0.445)

1.094 (0.353)

0.988 (0.327)

1.283 (0.459)

1.436 (0.521)

1.422 (0.512)

1.221 (0.428)

1.347 (0.492)

Mean (SD) post-bronchodilator

           

 FEV1, L

1.754 (0.468)

1.146 (0.274)

1.820 (0.472)

1.690 (0.455)

1.269 (0.370)

1.167 (0.336)

1.476 (0.475)

1.619 (0.532)

1.614 (0.522)

1.406 (0.444)

1.536 (0.504)

 FEV1 % predicted

62.94 (7.98)

41.09 (5.54)

63.66 (8.08)

62.09 (7.72)

44.86 (9.80)

42.58 (9.06)

53.91 (12.86)

56.75 (12.57)

56.65 (12.55)

52.52 (12.83)

55.10 (12.81)

FEV1/FVC ratio, % (SD)

54.54 (8.21)

42.82 (9.62)

54.66 (8.33)

54.54 (8.14)

44.13 (9.83)

43.79 (10.24)

48.49 (10.42)

52.87 (9.89)

51.87 (9.96)

47.74 (10.67)

50.32 (10.42)

Baseline pulmonary medication, n (%)

           

 Any

761 (73.0)

473 (83.0)

349 (71.8)

356 (73.7)

213 (85.2)

321 (80.3)

943 (100)

297 (43.8)

632 (62.4)

608 (100)

1240 (76.5)

 ICS

337 (32.3)

269 (47.2)

131 (27.0)

173 (35.8)

125 (50.0)

179 (44.8)

608 (64.5)

0 (0.0)

0 (0.0)

608 (100)

608 (37.5)

 LAMA

334 (32.1)

221 (38.8)

157 (32.3)

150 (31.1)

105 (42.0)

148 (37.0)

560 (59.4)

0 (0.0)

277 (27.3)

283 (46.5)

560 (34.5)

 SAMA

68 (6.5)

56 (9.8)

24 (4.9)

38 (7.9)

21 (8.4)

41 (10.3)

88 (9.3)

36 (5.3)

55 (5.4)

69 (11.3)

124 (7.6)

 LABA

365 (35.0)

261 (45.8)

149 (30.7)

184 (38.1)

117 (46.8)

179 (44.8)

629 (66.7)

0 (0.0)

144 (14.2)

485 (79.8)

629 (38.8)

 SABA

470 (45.1)

343 (60.2)

211 (43.4)

223 (46.2)

159 (63.6)

224 (56.0)

542 (57.5)

276 (40.7)

447 (44.1)

371 (61.0)

818 (50.5)

  1. GOLD A–D based on modified Medical Research Council dyspnoea scale. The inclusion criteria for this study only included patients with GOLD 2 or 3 disease; however, 8 patients were classed as GOLD 4 and 1 patient as GOLD 1 based on entrance spirometry results. As this is a small number, these patients were not included in the GOLD 2/3 subgroup analysis and are not included in the table
  2. GOLD Global initiative for chronic Obstructive Lung Disease, ICS inhaled corticosteroids, SD standard deviation, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, LAMA long-acting muscarinic antagonist, SAMA short-acting muscarinic antagonist, LABA long-acting β2-agonist, SABA short-acting β-agonist
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Respiratory Research

ISSN: 1465-993X

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