Table 3 Cumulative number (percentage) of patients experiencing a worsening of COPD by visit, and median time to worsening (per protocol set)
LABA/LAMA FDC (N = 292) | Triple therapy (N = 675) | |
|---|---|---|
Worsening of COPD according to exacerbations or CAT | ||
Cumulative number (percentages) of patients experiencing a worsening of COPD by visit | ||
Visit 1 (after approx. 3 months) | 40 (13.7) | 192 (28.4) |
Visit 2 (after approx. 6 months) | 64 (21.9) | 277 (41.0) |
Visit 3 (after approx. 9 months) | 79 (27.1) | 330 (48.9) |
Visit 4 (after approx. 12 months) | 95 (32.5) | 376 (55.7) |
Median time until worsening of COPD [95% CI] in months | Not analysed | 11.93 [9.17; 12.19] |
Cox regression model, LABA/LAMA FDC vs triple therapy, hazard ratio [95% CI]; p value | 2.004 [1.600; 2.512]; < 0.001 | |
Worsening of COPD according to CAT | ||
Cumulative number (percentages) of patients experiencing a worsening of COPD by visit | ||
Visit 1 (after approx. 3 months) | 32 (11.0) | 149 (22.1) |
Visit 2 (after approx. 6 months) | 46 (15.8) | 213 (31.6) |
Visit 3 (after approx. 9 months) | 54 (18.5) | 258 (38.2) |
Visit 4 (after approx. 12 months) | 63 (21.6) | 290 (43.0) |
Median time until worsening of COPD [95% CI] in months | Not analysed | 14.23 [13.93; –] |
Cox regression model, LABA/LAMA FDC vs triple therapy, hazard ratio [95% CI]; p value | 2.223 [1.692; 2.921]; < 0.001 | |
Worsening of COPD according to exacerbations | ||
Cumulative number (percentages) of patients experiencing a worsening of COPD by visit | ||
Visit 1 (after approx. 3 months) | 15 (5.1) | 70 (10.4) |
Visit 2 (after approx. 6 months) | 27 (9.2) | 113 (16.7) |
Visit 3 (after approx. 9 months) | 39 (13.4) | 151 (22.4) |
Visit 4 (after approx. 12 months) | 49 (16.8) | 190 (28.1) |
Median time until worsening of COPD [95% CI] in months | Not analysed | Not analysed |
Cox regression model, LABA/LAMA FDC vs triple therapy, hazard ratio [95% CI]; p value | 1.723 [1.258; 2.360]; < 0.001 | |