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Table 1 Baseline demographics and patient characteristics (treated seta)

From: Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies

 

Study 1222.37

Study 1222.38

(n = 151)

(n = 157)

Male, n (%)

116 (76.8)

116 (73.9)

Mean (SD) age, years

60.6 (7.7)

60.6 (7.7)

Smoking status, n (%)

  

 Ex-smoker

 Current smoker

84 (55.6)

67 (44.4)

92 (58.6)

65 (41.4)

Mean (SD) smoking history, pack-years

45.3 (22.5)

50.0 (29.0)

Mean (SD) pre-bronchodilator at screening

  

 FEV1, L

 FEV1 % predicted

1.46 (0.54)

48.5 (14.5)

1.56 (0.53)

51.6 (14.2)

Mean (SD) post-bronchodilator at screening

  

 FEV1, L

 Change from pre- to post-bronchodilator

1.66 (0.55)

1.70 (0.53)

  FEV1, L

0.19 (0.18)

0.14 (0.19)

 FEV1 % predicted

55.1 (14.4)

56.1 (13.1)

 Change from pre- to post-bronchodilator

  

  FEV1, %

15.7 (14.7)

10.9 (14.3)

GOLD, n (%)

  

 1 (≥80 %)

 2 (50– <80 %)

 3 (30– <50 %)

 4 (<30 %)

0 (0.0)

100 (66.2)

43 (28.5)

8 (5.3)

1 (0.6)b

111 (70.7)

41 (26.1)

4 (2.5)

Patients with FRC ≥120 % predicted normal, n (%)

108 (71.5)

116 (73.9)

  1. a4 patients in Study 1222.37 and 3 in Study 1222.38 were included in the treated set but not the full analysis set because they did not have baseline or primary end point data; b1 patient with a predicted FEV1 of 80.4 %. This was classed as a protocol violation; the patient was included in the full analysis set but was excluded from the per protocol set
  2. SD standard deviation, FEV 1 forced expiratory volume in 1 s, GOLD Global initiative for chronic Obstructive Lung Disease, FRC functional residual capacity