Urinary cortisol excretion outside the normal range* and change from baseline relative to the normal range (intent-to-treat population)
| Relative to normal range* | FF/VI 100/25 µg OD (N=201) | FF/VI 200/25 µg OD (N=202) | FP 500 µg BD (N=100) | |
|---|---|---|---|---|
| Baseline | n | 166 | 169 | 94 |
| n (%) | High | 12 (7) | 14 (8) | 7 (7) |
| Normal | 150 (90) | 146 (86) | 85 (90) | |
| Low | 4 (2) | 9 (5) | 2 (2) | |
| Any visit post-baseline | n | 183 | 179 | 87 |
| n (%) | High | 32 (17) | 31 (17) | 11 (13) |
| Normal | 132 (72) | 138 (77) | 57 (66) | |
| Low | 19 (10) | 10 (6) | 19 (22) | |
| Change from baseline | n | 156 | 156 | 83 |
| (any visit post-baseline) | To high | 25 (16) | 21 (13) | 8 (10) |
| n (%) | To normal or NC | 119 (76) | 126 (81) | 58 (70) |
| To low | 12 (8) | 9 (6) | 17 (20) |
*Normal range is 11–138 nmol/24 h.
BD, twice daily; FF, fluticasone furoate; FP, fluticasone propionate; NC, no change; OD, once daily; VI, vilanterol.