Table 2

Changes in FEV1% predicted at week 24 (intention-to-treat population)

CDPITISOverallAdjusted treatmentcomparison95% CI
Patients using LOCF, n1831903730.9800.943 to 1.018
Mean (SD of logs)0.964 (0.1994)0.986 (0.1898)0.975 (0.1946)−0.97−2.74 to 0.86*
Median0.9680.9820.978−0.98−2.74 to 0.86†
Minimum, maximum0.484, 1.8600.450, 1.9570.450, 1.957
Adjusted mean0.9600.9790.970
‘Completed’ patients, n1531713240.9940.955 to 1.035
Mean (SD of logs)0.988 (0.1916)0.993 (0.1913)0.991 (0.1912)−0.29−2.21 to 1.71*
Median0.9880.9880.988−0.29−2.20 to 1.70†
Minimum, maximum0.502, 1.8600.450, 1.9570.450, 1.957
Adjusted mean0.9770.9830.980
  • Data logarithmically transformed, ANCOVA analysis. ‘Completed’ patients are defined as patients who completed the study; that is, those who have a baseline and week 24 result.

  • *Adjusted difference (CDPI – TIS) obtained using formula (M× (ratio−1)), where M is the unadjusted TIS geometric mean.

  • †Adjusted difference (CDPI – TIS) obtained using formula (M ×( ratio−1)), where M is the TIS geometric mean adjusted for baseline FEV1% predicted and pooled centre.

  • ANCOVA, analysis of covariance; CDPI, Colobreathe dry powder for inhalation; FEV1, forced expiratory volume in 1 s; LOCF, last observation carried forward; TIS, tobramycin inhaler solution.