Table 3. Forced expiratory volume in 1 s (FEV1) estimates of efficacy for the COLO/DPI/02/06 trial
AnalysisPopulationData included in analysisCDPITISAdjusted mean difference between groups in FEV1 % from baseline#Lower limit of 95% CIUpper limit of 95% CISatisfies non-inferiority?
ANCOVA analysis on the original absolute scaleITTLOCF183190-1.16-3.150.84No
Completers153171-0.43-2.591.72Yes
PPLOCF141157-1.49-3.790.81No
Completers120141-0.99-3.481.51No
Logarithmic analysisITTLOCF183190-0.98-2.740.86Yes
Completers153171-0.29-2.201.70Yes
PPLOCF141157-1.10-3.080.97No
Completers120141-0.56-2.711.70Yes
Non-parametric analysisITTLOCF183190-0.56+-2.16+NRYes
Completers1531710.05+-1.61+NRYes
PPLOCF141157-0.67+-2.57+NRYes
Completers120141-0.15+-2.14+NRYes
  • Data are presented as n or %. Bold denotes protocol-defined analyses. CDPI: colistimethate sodium dry powder for inhalation; TIS: tobramycin inhaled solution; ITT: intention-to-treat; PP: per protocol; LOCF: last observation carried forward; NR: not reported. #: adjusted for baseline FEV1 % and pooled centre; : this should no lower than -3% to satisfy non-inferiority criteria; +: median difference, CI determined using distribution-free methods based on the Wilcoxon rank sum test, without adjustment for pooled centre; unclear if adjusted for baseline FEV1 %.