Table 4 Day 85 TDI responders by patient subgroup
Subgroups | Revefenacin 175 μg (n = 395) | Placebo (n = 417) |
|---|---|---|
ITT | ||
Evaluable n | 280 | 271 |
Odds ratio (95% CI) | 1.46 (0.96, 2.22), p = 0.0760 | |
FEV130%–< 50% pred | ||
Evaluable n | 95 | 77 |
Odds ratio (95% CI) | 2.37 (1.10, 5.08), p = 0.0268 | |
FEV1 < 30% pred | ||
Evaluable n | 15 | 7 |
Odds ratio (95% CI) | 0.31 (0.03, 2.88), p = 0.3016 | |
2011 GOLD category D | ||
Evaluable n | 101 | 80 |
Odds ratio (95% CI) | 1.95 (0.93, 4.09), p = 0.0789 | |
ICS use | ||
Evaluable n | 131 | 100 |
Odds ratio (95% CI) | 1.04 (0.54, 1.98), p = 0.9115 | |
LABA or ICS/LABA use | ||
Evaluable n | 116 | 81 |
Odds ratio (95% CI) | 1.16 (0.57, 2.35), p = 0.6845 | |
> 65 years | ||
Evaluable n | 131 | 115 |
Odds ratio (95% CI) | 1.43 (0.76, 2.68), p = 0.2687 | |
> 75 years | ||
Evaluable n | 28 | 25 |
Odds ratio (95% CI) | 4.72 (1.02, 21.86), p = 0.0470 | |
Reversible to ipratropium and albuterol | ||
Evaluable n | 63 | 50 |
Odds ratio (95% CI) | 1.72 (0.67, 4.38), p = 0.2583 | |
History of CV disease | ||
Evaluable n | 18 | 25 |
Odds ratio (95% CI) | 1.62 (0.93, 2.22), p = 0.5397 | |
History of diabetes | ||
Evaluable n | 61 | 51 |
Odds ratio (95% CI) | 1.41 (0.55, 3.64), p = 0.4719 | |
History of cognitive/mental impairments | ||
Evaluable n | 41 | 38 |
Odds ratio (95% CI) | 1.03 (0.34, 3.10), p = 0.9552 | |