Table 4.
Morning serum cortisol concentration (nmol/l) for patients who provided valid data (8 am to 10 am samples only) during double blind period
| Time point | Placebo (n=370)
|
Fluticasone propionate (n=372)
|
|||||
|---|---|---|---|---|---|---|---|
| Patients with valid samples | Geometric mean* serum cortisol (CV†) | No (%) of patients with values below normal range (150-700 nmol/l) | Patients with valid samples | Geometric mean serum cortisol * (CV†) | No (%) of patients with values below normal range (150-700 nmol/l) | ||
| Baseline | 265 | 344 (33) | 5 (2) | 265 | 353 (31) | 4 (2) | |
| 6 months | 260 | 345 (33) | 3 (1) | 272 | 311 (42) | 2 (1) | |
| 12 months | 209 | 352 (34) | 3 (1) | 238 | 316 (45) | 13 (5) | |
| 24 months | 136 | 345 (34) | 1 (1) | 160 | 303 (44) | 5 (3) | |
| 36 months | 93 | 354 (33) | 1 (1) | 96 | 310 (35) | 4 (4) | |
| >1 point during double blind treatment | 299 | — | 4 (1) | 331 | — | 17 (5) | |
*
Least squares means from analysis of covariance of log transformed serum cortisol concentrations were back transformed to give geometric means.
†
CV=coefficient of variation (%).