Table 2

Lower respiratory symptoms, lung function, FeNO, PC20 and ACQ-6

PlaceboTimapiprantDifference (timapiprant – placebo) (95% CI)P value
Total lower respiratory symptom score day 0–1418.0 (9.8 to 51.5)21.0 (13.3 to 46.5)3.0 (−29.0 to 17.0)0.78
Morning PEF % change from baseline day 0–14 AUC−41.3 (−145.7 to −2.1)−73.4 (−171.0 to −40.3)−32.1 (−102.7 to 77.6)0.58
Morning FEV1 % change from baseline day 0–14 AUC−13.5 (−93.3 to 17.6)−45.1 (−106.6 to −3.2)−31.7 (−84.5 to 59.5)0.35
FeNO % change from baseline day 0–10 AUC−2 (−106 to 264)294 (−40 to 459)296 (−98 to 494)0.28
PC20 day 71.95 (0.63 to 3.17)1.08 (0.31 to 7.28)−0.88 (−2.32 to 4.74)0.58
ACQ-6 day 10; mean (SD)1.49 (0.73)1.32 (0.70)−0.17 (−0.70 to 0.37)0.53
  • Data are median (IQR) except where shown. 95% CIs for median values derived via bootstrapping. AUC scores were derived using the trapezoidal method and are based on AUC over x-axis—AUC under x-axis. Note: one subject in the placebo group was unable to complete PC20 on day 7 for logistical reasons and is therefore excluded.

  • ACQ, Asthma Control Questionnaire; AUC, area under the curve; FeNO, Fractional exhaled nitric oxide; FEV1, Forced expiratory volume in 1 second; PC20, Provocation concentration of histamine required to produce a 20% drop in FEV1; PEF, peak expiratory flow.