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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*, years49.3 (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/m229.89 (7.31)29.40 (7.52)29.02 (7.68)29.44 (7.49)
Smoking status, n (%)
Never smoked127 (89)132 (95)129 (93)388 (92)
Former smoker16 (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, years15.06 (14.40)13.82 (12.92)15.61 (13.54)14.83 (13.63)
Age of onset of asthma, years33.9 (16.71)34.7 (17.90)32.6 (17.13)33.8 (17.23)
Pre-bronchodilator FEV1, Ln =143n =137n =139n =419
2.11 (0.71)2.18 (0.72)2.15 (0.60)2.14 (0.68)
Pre-bronchodilator predicted FEV1, %n =143n =137n =139n =419
67.90 (12.09)68.85 (12.00)69.11 (11.12)68.61 (11.72)
Pre-bronchodilator FEV1/FVC, ration =143n =137n =139n =419
0.70 (0.08)0.70 (0.09)0.72 (0.09)0.71 (0.09)
Reversibility, %n =142n =137n =138n =417
25.97 (15.89)28.21 (18.64)30.75 (22.84)28.29 (19.36)
SGRQ total score36.96 (17.45)35.56 (15.75)36.30 (18.06)36.28 (17.09)
AQLQ total score5.03 (0.93)5.10 (0.87)5.14 (0.80)5.09 (0.87)
ACQ-6 score1.70 (0.55)1.69 (0.54)1.59 (0.53)1.66 (0.54)
ACQ-6 control category¶§, n (%)
Partially controlled51 (36)53 (38)60 (43)164 (39)
Inadequately controlled92 (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/day1.30 (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 (%)
0123 (86)108 (78)128 (92)359 (85)
116 (11)22 (16)9 (6)47 (11)
≥24 (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