Table 2– Summary of outcome measures using the mixed model approach with fixed subject effects
PlaceboDornase alfaTreatment effect#p-value
BeforeAfterBeforeAfter
LCI8.75±1.728.52±1.198.31±1.487.69±1.65-0.90±1.440.02
FVC % pred93.08±8.9195.64±8.60102.76±12.35108.08±11.42-3.61±9.530.14
FVC z-score-0.55±0.69-0.36±0.690.24±0.990.66±0.92-0.28±0.780.16
FEV1% pred89.68±10.6890.44±7.8092.09±6.5797.72±9.960.076±8.430.97
FEV1 z-score-0.84±0.85-0.79±0.63-0.62±0.54-0.176±0.770.015±0.160.93
FEF25–75% % pred76.52±17.8084.01±19.9477.33±23.7185.54±30.366.09±10.340.03
FEF25–75% z-score-1.08±0.85-0.73±0.91-1.09±1.10-0.76±1.340.28±0.460.03
CFQ-R respiratory domain79.17±17.6873.89±16.9880.56±12.5070.07±21.240.84±17.220.87
CFQ-R parent respiratory domain75.42±12.5879.53±21.3080.95±16.2776.39±22.579.78±18.380.09
  • Data are presented as mean±sd, unless otherwise stated. % predicted spirometry values were calculated using the Stanojevic et al. 13 reference equations. LCI: lung clearance index; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; FEF25–75%: forced expiratory flow at 25–75% of FVC; % pred: % predicted; CFQ-R: cystic fibrosis questionnaire-revised. #: estimated treatment effects (placebo versus dornase alfa) from the model; : p-value for comparison of post-placebo to post-dornase alfa, while incorporating the period-dependent baseline (pre) measures.