Table 4.
Assessment of fixed-dose budesonide/formoterol fumarate combination therapy on changes in PRO measures and FEV1 (% predicted) in patients with COPD or ACO (n = 877)
| COPD (n = 778) | ACO (n = 99) | |||||
|---|---|---|---|---|---|---|
| Visit 1 | Visit 3 | p value | Visit 1 | Visit 3 | p value | |
| COPD assessment test | ||||||
| All patients | 24.2 (5.7) | 18.2 (5.1) | < 0.001 | 23.7 (6.5) | 18.3 (4.7) | < 0.001 |
| Inhaler-naïve patients | 23.8 (5.6) | 17.9 (4.9) | < 0.001 | 23.1 (6.0) | 18.7 (5.0) | < 0.001 |
| Patients switching to Easyhaler® | 24.4 (5.8) | 18.3 (5.1) | < 0.001 | 23.8 (6.6) | 18.3 (4.6) | < 0.001 |
| mMRC dyspnea scale | ||||||
| All patients | 1.9 (0.9) | 1.2 (0.8) | < 0.001 | 1.8 (0.9) | 1.1 (0.9) | < 0.001 |
| Inhaler-naïve patients | 1.7 (0.8) | 1.0 (0.7) | < 0.001 | 1.5 (0.9) | 0.8 (0.8) | 0.002 |
| Patients switching to Easyhaler® | 2.0 (0.9) | 1.2 (0.8) | < 0.001 | 1.9 (0.9) | 1.1 (0.9) | < 0.001 |
| FEV 1 (% predicted) | ||||||
| All patients | 51.3 (17.0) | 58.6 (17.9) | < 0.001 | 56.7 (18.3) | 62.4 (20.2) | < 0.001 |
| Inhaler-naïve patients | 54.9 (18.0) | 63.8 (19.5) | < 0.001 | 54.4 (17.3) | 64.1 (17.1) | < 0.001 |
| Patients switching to Easyhaler® | 49.9 (16.4) | 56.6 (16.9) | < 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, COPD chronic obstructive pulmonary disease, mMRC modified medical research council, PRO patient-reported outcome