Table 3

Trough FEV6, FVC and IC: treatment comparisons versus placebo at week 6

 PlaceboPH-797804 dose
0.5 mg3 mg6 mg10 mg
FEV6 (ml)
 N (baseline)4218446542
 Baseline, mean (SD)2170 (610)2410 (560)2480 (830)2680 (630)2590 (820)
 N (week 6)4017405839
 Adjusted mean change−77−2381117
 SE of the mean3958383239
 95% CI(−153 to −1)(−117 to 113)(−37 to 113)(−52 to 73)(−59 to 93)
 Difference between means*751158794
 SE of difference*70545055
 95% one-sided lower limit for difference*−412644
 p Value (difference between means)*0.1430.0170.0420.044
FVC (ml)
 N (baseline)4218446542
 Baseline, mean (SD)2630 (770)2850 (680)2960 (1020)3190 (790)2960 (940)
 N (week 6)4017405839
 Adjusted mean change−91−2−12038
 SE of the mean4263413442
 95% CI(−173 to –8)(−127 to 123)(−83 to 80)(−48 to 88)(−45 to 120)
 Difference between means*8989111128
 SE of difference*76595459
 95% one-sided lower limit for difference*−37-82130
 p Value (difference between means)*0.1220.0650.0220.016
IC (ml)
 N (baseline)4218446542
 Baseline, mean (SD)1920 (560)2040 (570)2130 (620)2310 (620)2210 (690)
 N4017405839
 Adjusted mean change−5352666643
 SE of the mean4162403441
 95% CI(−133 to 27)(−70 to 174)(−13 to 145)(0 to 133)(−38 to 123)
 Difference between means*10511911996
 SE of difference*74575358
 95% one-sided lower limit for difference*−1725320
 p Value (difference between means)*0.0780.0190.0130.049
  • *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.

  • IC, inspiratory capacity; FEV1, forced expiratory volume in 1 s; FEV6, forced expiratory volume in 6 s; FVC, forced vital capacity.