Table 1.
Baseline demographics and clinical characteristics at screening and randomisation (ITT population)
| 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) |
Data are mean (SD) unless otherwise stated
*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).
§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).
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