Table 3.
Assessment of fixed-dose budesonide/formoterol fumarate combination therapy on changes in PRO measures and FEV1 (% predicted) in patients with asthma or ACO (n = 720)
| Asthma (n = 621) | ACO (n = 99) | |||||
|---|---|---|---|---|---|---|
| Visit 1 | Visit 3 | p value | Visit 1 | Visit 3 | p value | |
| Asthma control test | ||||||
| All patients | 14.2 (4.1) | 21.0 (2.7) | < 0.001 | 13.6 (4.1) | 18.7 (3.1) | < 0.001 |
| Inhaler-naïve patients | 14.3 (4.0) | 21.1 (2.6) | < 0.001 | 14.6 (3.0) | 18.9 (1.9) | 0.001 |
| Patients switching to Easyhaler® | 14.2 (4.2) | 20.9 (2.7) | < 0.001 | 13.4 (4.3) | 18.7 (3.3) | < 0.001 |
| Mini-AQLQ | ||||||
| All patients | 3.8 (0.9) | 5.2 (0.7) | < 0.001 | 3.7 (0.9) | 4.6 (0.8) | < 0.001 |
| Inhaler-naïve patients | 3.9 (0.9) | 5.3 (0.7) | < 0.001 | 4.0 (0.8) | 4.7 (0.7) | < 0.001 |
| Patients switching to Easyhaler® | 3.8 (0.9) | 5.1 (0.8) | < 0.001 | 3.6 (0.9) | 4.6 (0.8) | < 0.001 |
| FEV 1 (% predicted) | ||||||
| All patients | 76.7 (19.3) | 85.3 (20.3) | < 0.001 | 56.7 (18.3) | 62.4 (20.2) | < 0.001 |
| Inhaler-naïve patients | 77.1 (19.6) | 85.8 (19.7) | < 0.001 | 54.4 (17.3) | 64.1 (17.1) | < 0.001 |
| Patients switching to Easyhaler® | 76.4 (19.1) | 85.0 (20.6) | < 0.001 | 57.2 (18.5) | 62.0 (20.8) | < 0.001 |
Data are presented as mean (SD). p values refer to Wilcoxon’s signed rank test of change from baseline (visit 1) at visit 3 (week 12 of treatment)
ACO asthma-COPD overlap, AQLQ asthma quality of life questionnaire, PRO patient-reported outcome