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Table 2 Summary of baseline demographics and disease characteristics in Phase III trials with tiotropium Respimat® in patients aged 12 to 75 years with persistent asthma – all treated patients

From: Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1

Trial

Age

Sex

Race

Never smoked

Duration of asthma

FEV1 at baseline

PEFd at baseline

(Treated patients)

Mean ± SD [years]

Male, n (%); Female, n (%)

White, n (%); Asian, n (%); Black a , n (%); American Indian b , n (%); Hawaiian c , n (%)

n (%)

Mean ± SD [years]

Mean ± SD [L]/[% pred.]

Weekly mean ± SD [mL/min]

Adolescents (12 to 17 years)

 RubaTinA-asthma® (N = 397)

14.3 ± 1.7

258 (65.0); 139 (35.0)

368 (92.7); 13 (3.3); 14 (3.5); 2 (0.5); 0

396 (99.7)

7.9 ± 4.1

2.75 ± 0.66/82.8 ± 10.6

360.0 ± 91.1

 PensieTinA-asthma® (N = 392)

14.2 ± 1.7

242 (61.7); 150 (38.3)

371 (94.6); 10 (2.6); 8 (2.0); 3 (0.8); 0

392 (100)

7.8 ± 3.9

2.53 ± 0.62/79.5 ± 11.5

346.1 ± 91.8

Adults (18 to 75 years)

 GraziaTinA-asthma® (N = 464)

42.9 ± 13.0

183 (39.4); 281 (60.6)

362 (78.0); 85 (18.3); 1 (0.2); 16 (3.4); 0

382 (82.3)

16.2 ± 11.9

2.42 ± 0.71/77.7 ± 11.9

369.8 ± 114.9

 MezzoTinA-asthma® (N = 2100)

43.1 ± 12.9

861 (41.0); 1239 (59.0)

1005 (47.9); 893 (42.5); 81 (3.9); 118 (5.6); 3 (0.1)

1756 (83.6)

21.8 ± 14.3

2.27 ± 0.65/75.1 ± 11.5

349.6 ± 117.2

 CadenTinA-asthma® (N = 285)

44.5 ± 12.7

109 (38.2); 176 (61.8)

0; 285 (100.0); 0; 0; 0

214 (75.1)

22.4 ± 14.2

2.28 ± 0.65/80.2 ± 12.5

375.5 ± 118.4

 PrimoTinA-asthma® (N = 912)

53.0 ± 12.4

361 (39.6); 551 (60.4)

759 (83.2); 103 (11.3); 47 (5.2); 1 (0.1); 2 (0.2)

692 (75.9)

30.3 ± 13.9

1.60 ± 0.54/56.0 ± 13.1

270.7 ± 111.1

  1. aOr African American. bOr Alaska Native. cOr Pacific Islander. dMeasured with AM® device at baseline at the same time of day before dosing occurred, i.e. morning PEF in the trials with morning dosing (PrimoTinA-asthma®), evening PEF in the trials with evening dosing (RubaTinA-asthma®, PensieTinA-asthma®, GraziaTinA-asthma®, MezzoTinA-asthma®, CadenTinA-asthma®)
  2. FEV1 = forced expiratory volume in one second; PEF = peak expiratory flow; SD = standard deviation