Mean percentage change in FEV1 over 12-week treatment period (final FEV1 minus initial FEV1 expressed as a percentage of initial FEV1) | |||||
Pretreatment (litres) | Post-treatment (litres) | Change in FEV1 (litres) (%) | 95% CI | p Value* | |
Mean (SD) | Mean (SD) | ||||
Mannitol alone | 1.68 (0.60) | 1.79 (0.63) | +0.11 (6.7%) | (0.00 to 0.23) | 0.055 |
RhDNase alone | 1.59 (0.59) | 1.70 (0.57) | +0.12 (7.2%) | (0.01 to 0.22) | 0.029 |
Mannitol + rhDNase | 1.65 (0.45) | 1.68 (0.62) | +0.03 (1.9%) | (−0.12 to 0.18) | 0.67 |
Comparison of mean percentage change in FEV1 between treatments, adjusted for baseline | |||||
Pretreatment (litres) | Post-treatment (litres) | Comparison with rhDNase alone (%) | |||
Mean (SD) | Mean (SD) | % Change | 95% CI | p Value† | |
RhDNase alone | 1.59 (0.59) | 1.70 (0.57) | |||
Mannitol alone | 1.68 (0.60) | 1.79 (0.63) | +2.8 | (−4.2 to +10.4) | 0.42 |
Mannitol + rhDNase | 1.65 (0.45) | 1.68 (0.62) | −4.3 | (−14.1 to +6.5) | 0.40 |
*p Values derived from paired t tests.
†p Values derived from regression analysis.
FEV1, forced expiratory volume in 1 s; rhDNase, recombinant human deoxyribonuclease.