TDI total focal score | Placebo | PH-797804 dose | |||
---|---|---|---|---|---|
0.5 mg | 3 mg | 6 mg | 10 mg | ||
N (baseline) | 42 | 18 | 44 | 65 | 42 |
Baseline, mean (SD) | 6.74 (2.20) | 6.89 (1.64) | 7.08 (1.92) | 6.80 (2.14) | 6.50 (2.38) |
N (week 6) | 40 | 17 | 40 | 58 | 40 |
Adjusted mean change | 1.580 | 1.090 | 2.527 | 2.571 | 1.443 |
SE of the mean | 0.459 | 0.701 | 0.455 | 0.379 | 0.460 |
95% CI | (0.674 to 2.485) | (−0.292 to 2.472) | (1.630 to 3.424) | (1.823 to 3.320) | (0.535 to 2.351) |
Difference between means* | −0.490 | 0.947 | 0.992 | −0.137 | |
SE of difference* | 0.838 | 0.646 | 0.596 | 0.650 | |
95% one-sided lower limit for difference* | −1.874 | −0.121 | 0.007 | −1.212 | |
p Value (difference between means)* | 0.720 | 0.072 | 0.049 | 0.583 |
*Comparisons are between each dose of PH-797804 and placebo using the full analysis set, which included all patients who were randomised and had a valid FEV1 measurement during the double-blind treatment phase.
FEV1, forced expiratory volume in 1 s; TDI, transition dyspnoea index.