Table 1.
Baseline characteristics
| Fevipiprant 150 mg N = 1092 | Fevipiprant 450 mg N = 1084 | Placebo N = 361 | Total N = 2537 | |
|---|---|---|---|---|
| Demographic characteristics | ||||
| Age, years, mean (SD) | 50.1 (14.95) | 50.1 (15.55) | 49.9 (14.99) | 50.1 (15.21) |
| Female sex, n (%) | 659 (60.3) | 666 (61.4) | 229 (63.4) | 1554 (61.3) |
| Disease characteristics | ||||
| Duration of asthma, years, n | 1090 | 1084 | 361 | 2535 |
| Mean (SD) | 21.01 (14.974) | 21.03 (15.243) | 19.75 (14.023) | 20.84 (14.960) |
| Number of asthma exacerbations in the previous year, n | 1092 | 1084 | 361 | 2357 |
| Mean (SD) | 1.39 (1.315) | 1.41 (1.264) | 1.45 (1.512) | 1.41 (1.323) |
| Atopic status—n (%) | ||||
| Yes | 670 (61.4) | 632 (58.3) | 218 (60.4) | 1520 (59.9) |
| No | 418 (38.3) | 450 (41.5) | 142 (39.3) | 1010 (39.8) |
| Missing | 4 (0.4) | 2 (0.2) | 1 (0.3) | 7 (0.3) |
| Prior participation in a fevipiprant phase 3 study, n (%) | ||||
| LUSTER-1/LUSTER-2 | 449 (41.1) | 442 (40.8) | 149 (41.3) | 1040 (41.0) |
| 150 mg QD | 254 (23.3) | 53 (4.9) | 51 (14.1) | 358 (14.1) |
| 450 mg QD | 48 (4.4) | 241 (22.2) | 47 (13.0) | 336 (13.2) |
| Placebo | 148 (13.6) | 148 (13.7) | 50 (13.9) | 346 (13.6) |
| ZEAL-1/ZEAL-2 | 330 (30.2) | 329 (30.4) | 107 (29.6) | 766 (30.2) |
| 150 mg QD | 218 (20.0) | 112 (10.3) | 53 (14.7) | 383 (15.1) |
| Placebo | 112 (10.3) | 217 (20.0) | 54 (15.0) | 383 (15.1) |
| Newly randomised | 313 (28.7) | 313 (28.9) | 105 (29.1) | 731 (28.8) |
| Smoking history—n (%) | ||||
| Never | 892 (81.7) | 906 (83.6) | 298 (82.5) | 2096 (82.6) |
| Former | 200 (18.3) | 178 (16.4) | 63 (17.5) | 441 (17.4) |
| Blood eosinophil at screening—n (%) | ||||
| ˂250 cells/μL | 434 (39.7) | 427 (39.4) | 149 (41.3) | 1010 (39.8) |
| ≥ 250 cells/μL | 635 (58.2) | 641 (59.1) | 202 (56.0) | 1478 (58.3) |
| Missing | 23 (2.1) | 16 (1.5) | 10 (2.8) | 49 (1.9) |
| Baseline spirometry | ||||
| Percent predicted FEV1 (%) (Pre-bronchodilator) | ||||
| n | 1079 | 1069 | 354 | 2502 |
| Mean | 61.0 | 60.5 | 60.9 | 60.8 |
| SD | 13.86 | 13.98 | 14.37 | 13.98 |
| FEV1 reversibility (%) | ||||
| n | 1069 | 1064 | 353 | 2486 |
| Mean | 21.9 | 22.9 | 24.0 | 22.6 |
| SD | 17.97 | 18.82 | 16.56 | 18.16 |
Age is calculated from date of screening and July 1st of the year of birth for adults. For adolescents, age is collected directly from Electronic Case Report Form (eCRF)
For all other variables, prior study baseline is used as the baseline value in patients who completed a prior Phase 3 study, and SPIRIT baseline is used as the baseline value in new patients
Duration of asthma is calculated as date of asthma first diagnosed until Visit 1. Blood eosinophil count at screening visit of prior study is considered for rollover patients. FEV1 reversibility is calculated as increase of FEV1 value after inhalation of bronchodilator relative to the FEV1 value before inhalation of bronchodilator. Reversible: increase of FEV1 value ≥ 12% and ≥ 200 mL Not reversible: change of FEV1 value < 12% or < 200 mL. FEV1 reversibility demonstrated at clinic at Visit 1 are presented. Percent predicted FEV1: percentage of FEV1 relative to the predicted normal value. For patients who completed a prior Phase 3 study, prior study baseline is used as the baseline value
BMI body mass index; FEV1 forced expiratory volume in one second; SD standard deviation