Table 1.
Demographics and patient characteristics (intention‐to‐treat (ITT) analysis set)
| AZD9412 (N = 61) | Placebo (N = 60) | Total (N = 121) | |
|---|---|---|---|
| Age in years, mean (SD) | 47.8 (13.0) | 47.7 (14.1) | 47.7 (13.5) |
| Sex, n (%) | |||
| Male | 13 (21.3) | 17 (28.3) | 30 (24.8) |
| Female | 48 (78.7) | 43 (71.7) | 91 (75.2) |
| Race, n (%) | |||
| White | 41 (68.3) | 44 (74.6) | 85 (71.4) |
| Asian | 12 (20.0) | 12 (20.3) | 24 (20.2) |
| Other | 7 (11.7) | 3 (5.1) | 10 (8.4) |
| BMI, kg/m2, mean (SD) | 29 (7.1) | 29 (5.5) | 29 (6.3) |
| Smoking status, n (%) | |||
| Never | 39 (63.9) | 40 (66.7) | 79 (65.3) |
| Current | 1 (1.6) | 3 (5.0) | 4 (3.3) |
| Former | 21 (34.4) | 17 (28.3) | 38 (31.4) |
| Lung function at screening | |||
| n | 58 | 56 | 114 |
| pre‐BD FEV1 in L mean (SD) | 2.2 (0.69) | 2.2 (0.81) | 2.2 (0.75) |
| FVC in L, mean (SD) | 3.0 (0.89) | 3.1 (1.00) | 3.1 (0.94) |
| Number of severe exacerbations in the last 24 mo, n (%) | |||
| 1 | 1 (1.6) | 0 | 1 (0.8) |
| 2 | 19 (31.1) | 24 (40.0) | 43 (35.5) |
| 3 | 22 (36.1) | 18 (30.0) | 40 (33.1) |
| 4 | 9 (14.8) | 11 (18.3) | 20 (16.5) |
| ≥5 | 10 (16.4) | 7 (11.7) | 17 (14.0) |
| Time since first symptoms of asthma a in years, median (range) | 21 (1.3, 55.0) | 20.5 (1.8, 58.0) | 21.0 (1.3, 58.0) |
| Time since last acute respiratory infection a in months, median (range) | 5.6 (0.9, 17.1) | 6.4 (1.0, 12.6) | 6.1 (0.9, 17.1) |
| Inhaled corticosteroid | |||
| Medium dose | 30 (49.2) | 29 (48.3) | 59 (48.8) |
| High dose | 19 (31.1) | 22 (36.7) | 41 (33.9) |
| Equivalence dose level not possible to establish | 12 (19.7) | 9 (15.0) | 21 (17.4) |
| LABA | 59 (96.7) | 59 (98.3) | 118 (97.5) |
| LTRA | 18 (29.5) | 17 (28.3) | 35 (28.9) |
| Theophylline | 7 (11.5) | 3 (5.0) | 10 (8.3) |
| Oral corticosteroids | 8 (13.1) | 9 (15.0) | 17 (14.0) |
Abbreviations: BD, bronchodilator; BMI, body mass index; FEV1, forced expiratory volume in 1 s; FVC, forced volume capacity; kg, kilograms; L, litre; LABA, long‐acting β2‐agonist; LTRA, leukotriene receptor agonist; m2, square metre; N, number; SD, standard deviation.
a
At screening.