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Table 1 Baseline demographics and clinical characteristics at screening and randomisation (ITT population)

From: A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids

 

Placebo (N =143)

UMEC 31.25 mcg (N =139)

UMEC 62.5 mcg (N =139)

Total (N =421)

Age*, years

49.3 (13.93)

48.7 (15.83)

48.5 (14.21)

48.8 (14.64)

Female, n (%)

106 (74)

94 (68)

98 (71)

298 (71)

Race: White, n (%)

131 (92)

127 (91)

129 (93)

387 (92)

BMI, kg/m2

29.89 (7.31)

29.40 (7.52)

29.02 (7.68)

29.44 (7.49)

Smoking status, n (%)

Never smoked

127 (89)

132 (95)

129 (93)

388 (92)

Former smoker

16 (11)

7 (5)

10 (7)

33 (8)

Number of pack years, mean (SD)

4.05 (2.74)

4.14 (2.70)

1.85 (1.79)

3.40 (2.62)

Duration of asthma, years

15.06 (14.40)

13.82 (12.92)

15.61 (13.54)

14.83 (13.63)

Age of onset of asthma†, years

33.9 (16.71)

34.7 (17.90)

32.6 (17.13)

33.8 (17.23)

Pre-bronchodilator FEV1, L

n =143

n =137

n =139

n =419

2.11 (0.71)

2.18 (0.72)

2.15 (0.60)

2.14 (0.68)

Pre-bronchodilator predicted FEV1, %

n =143

n =137

n =139

n =419

67.90 (12.09)

68.85 (12.00)

69.11 (11.12)

68.61 (11.72)

Pre-bronchodilator FEV1/FVC, ratio

n =143

n =137

n =139

n =419

0.70 (0.08)

0.70 (0.09)

0.72 (0.09)

0.71 (0.09)

Reversibility, %

n =142

n =137

n =138

n =417

25.97 (15.89)

28.21 (18.64)

30.75 (22.84)

28.29 (19.36)

SGRQ total score

36.96 (17.45)

35.56 (15.75)

36.30 (18.06)

36.28 (17.09)

AQLQ total score

5.03 (0.93)

5.10 (0.87)

5.14 (0.80)

5.09 (0.87)

ACQ-6 score

1.70 (0.55)

1.69 (0.54)

1.59 (0.53)

1.66 (0.54)

ACQ-6 control category¶§, n (%)

Partially controlled

51 (36)

53 (38)

60 (43)

164 (39)

Inadequately controlled

92 (64)

85 (62)

79 (57)

256 (61)

E-RS total score±

7.58 (5.58)

7.20 (5.11)

7.44 (5.52)

7.41 (5.40)

Rescue medication use±, puffs/day

1.30 (1.46)

1.30 (1.61)

1.00 (1.21)

1.20 (1.44)

Number of severe exacerbations in the 12 months prior to screening, n (%)

0

123 (86)

108 (78)

128 (92)

359 (85)

1

16 (11)

22 (16)

9 (6)

47 (11)

≥2

4 (3)

9 (6)

2 (1)

15 (4)

  1. Data are mean (SD) unless otherwise stated
  2. *Age is derived using the date of the pre-screening visit. Only year of birth is collected. Day and month of birth are imputed as 30 June. †Calculated based on age and duration of asthma at pre-screening. Baseline value was defined as score recorded at the Randomisation visit (Visit 2/Day 1).
  3. §ACQ-6 score 0.75 to <1.5: partially controlled; ACQ-6 score ≥1.5: inadequately controlled. ±Baseline value was defined as the mean over the last 14 days during the run-in period prior to study treatment start date (Randomisation).
  4. ACQ-6 Asthma Control Questionnaire-6, AQLQ Asthma Quality of Life Questionnaire, BMI body mass index, E-RS total score Evaluating Respiratory Symptoms, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, ITT intent-to-treat, SD standard deviation, SGRQ St George’s Respiratory Questionnaire, UMEC umeclidinium
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Respiratory Research

ISSN: 1465-993X

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