Incidence of severe exacerbations, in total and by subtype
| Incidence | BUD/FORM maintenance and reliever therapy | Conventional best practice | Treatment comparison# | p-value¶ |
| Subjects | 772 | 766 | ||
| Severe asthma exacerbations | ||||
| At least one event | 61 (7.9) | 63 (8.2) | ||
| Total events | 69 | 77 | ||
| Total days with event | 609 | 725 | ||
| Events per patient per year | 0.19 (0.15–0.24) | 0.21 (0.17–0.26) | 0.92 (0.67–1.28) | 0.63 |
| Oral glucocorticosteroid | ||||
| At least one event | 57 (7.4) | 55 (7.2) | ||
| Total events | 65 | 65 | ||
| Total days with event | 590 | 709 | ||
| Events per patient per year | 0.18 (0.14–0.23) | 0.17 (0.14–0.22) | 1.03 (0.73–1.45) | 0.86 |
| Emergency room treatment | ||||
| At least one event | 16 (2.1) | 23 (3.0) | ||
| Total events | 16 | 28 | ||
| Total days with event | 16 | 28 | ||
| Hospitalisation | ||||
| At least one event | 0 (0.0) | 1 (0.1) | ||
| Total events | 0 | 1 | ||
| Total days with event | 0 | 5 | ||
| Hospitalisation and/or emergency room treatment | ||||
| Events per patient per year | 0.04 (0.03–0.07) | 0.08 (0.05–0.11) | 0.59 (0.32–1.09) | 0.09 |
Data are presented as n, n (%) or n (95% confidence interval), unless otherwise stated. BUD/FORM: budesonide/formoterol. #: ratio of BUD/FORM maintenance and reliever therapy to conventional best practice; ¶: derived using Poisson regression analysis.