Rescue medication usage (daily no. of puffs averaged over each week) | Placebo | PH-797804 dose | |||
---|---|---|---|---|---|
0.5 mg | 3 mg | 6 mg | 10 mg | ||
N (baseline) | 40 | 16 | 43 | 63 | 42 |
Baseline, mean (SD) | 3.40 (2.84) | 2.03 (2.30) | 3.50 (2.47) | 3.42 (4.81) | 2.55 (2.34) |
N (week 6) | 38 | 15 | 40 | 54 | 38 |
Adjusted mean change (puffs per day) | 0.309 | 0.025 | −0.165 | −0.351 | 0.115 |
SE of the mean | 0.249 | 0.395 | 0.241 | 0.204 | 0.246 |
95% CI | (−0.183 to 0.801) | (−0.754 to 0.805) | (−0.641 to 0.311) | (−0.753 to 0.052) | (−0.372 to 0.601) |
Difference between means* | −0.283 | −0.473 | −0.659 | −0.194 | |
SE of difference* | 0.467 | 0.346 | 0.322 | 0.351 | |
95% one-sided lower limit for difference* | 0.490 | 0.100 | −0.127 | 0.386 | |
p Value (difference between means)* | 0.273 | 0.087 | 0.021 | 0.291 |
*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;