Changes in FEV1% predicted at week 24 (per protocol population)
| CDPI | TIS | Overall | Adjusted treatment comparison | 95% CI | |
|---|---|---|---|---|---|
| Patients using LOCF, n | 141 | 157 | 298 | 0.977 | 0.935 to 1.020 |
| Mean (SD of logs) | 0.974 (0.2040) | 0.997 (0.1957) | 0.986 (0.1997) | −1.10 | −3.07 to 0.96* |
| Median | 0.968 | 0.988 | 0.983 | −1.10 | −3.08 to 0.97† |
| Minimum, maximum | 0.502, 1.860 | 0.450, 1.957 | 0.450, 1.957 | ||
| Adjusted mean | 0.965 | 0.988 | 0.977 | ||
| ‘Completed’ patients, n | 120 | 141 | 261 | 0.988 | 0.943 to 1.036 |
| Mean (SD of logs) | 0.997 (0.1992) | 1.005 (0.1967) | 1.001 (0.1975) | −0.56 | −2.70 to 1.70* |
| Median | 0.990 | 0.995 | 0.993 | −0.56 | −2.71 to 1.70† |
| Minimum, maximum | 0.502, 1.860 | 0.450, 1.957 | 0.450, 1.957 | ||
| Adjusted mean | 0.981 | 0.992 | 0.987 |
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.