Changes in FEV1% predicted at week 24 (intention-to-treat population)
| CDPI | TIS | Overall | Adjusted treatment comparison | 95% CI | |
|---|---|---|---|---|---|
| Patients using LOCF, n | 183 | 190 | 373 | 0.980 | 0.943 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* |
| Median | 0.968 | 0.982 | 0.978 | −0.98 | −2.74 to 0.86† |
| Minimum, maximum | 0.484, 1.860 | 0.450, 1.957 | 0.450, 1.957 | ||
| Adjusted mean | 0.960 | 0.979 | 0.970 | ||
| ‘Completed’ patients, n | 153 | 171 | 324 | 0.994 | 0.955 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* |
| Median | 0.988 | 0.988 | 0.988 | −0.29 | −2.20 to 1.70† |
| Minimum, maximum | 0.502, 1.860 | 0.450, 1.957 | 0.450, 1.957 | ||
| Adjusted mean | 0.977 | 0.983 | 0.980 |
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.