Table 3.
Total cortisol concentrations and normal response to ACTH challenge (randomized safety population)
| Parameter, n/N a (%) | Budesonide foam (n = 655)b | Placebo (n = 278)b |
|---|---|---|
| Total cortisol >5 µg/dL (138 nmol/L)c | ||
| Baseline | 622/638 (97.5) | 275/278 (98.9) |
| Week 1 | 224/263 (85.2) | 264/269 (98.1) |
| Week 2 | 315/366 (86.1) | 263/266 (98.9) |
| Week 4 | 539/565 (95.4) | 243/249 (97.6) |
| Week 6 | 211/224 (94.2) | 234/241 (97.1) |
| Week 8 | 65/69 (94.2) | – |
| Normal response to ACTH challenged,e | ||
| Baseline | 261/266 (98.1) | 275/278 (98.9) |
| Week 6 | 186/216 (86.1) | 226/235 (96.2) |
ACTH adrenocorticotropic hormone
aDenominator N is the number of patients with a value at each given week during the study
bOnly patients in the four randomized studies were included
cLower limit of normal
dThe normal response to ACTH challenge, defined by protocol as a cortisol concentration of > 18 µg/dL (500 nmol/L) at 30 min following ACTH challenge
eData based on patients in BUCF3001 and BUCF3002 studies