Primary and secondary outcome measures at randomisation and week 8 for subjects with no change in maintenance prednisolone dose
| Ciclesonide (n=12) | Placebo (n=12) | ||||||
|---|---|---|---|---|---|---|---|
| Randomisation | Week 8 | p Value | Randomisation | Week 8 | p Value | Between group p | |
| Sputum eosinophils (%)* | 0.0 (0.0–2.3) (n=8) | 1.4 (0.5–3.5) (n=9) | 0.499 | 0.0 (0.0–2.3) (n=8) | 4.5 (1.0–17.5) (n=11) | 0.014 | 0.028 |
| Sputum neutrophils (%)* | 85.5 (62.2–96.9) (n=8) | 58.0 (51.2–88.5) (n=9) | 0.028 | 84.0 (77.1–91.6) (n=8) | 70.5 (56.5–90.0) (n=11) | 0.400 | 0.297 |
| FEV1 (litres)† | 2.5 (0.7) | 2.6 (0.8) | 0.692 | 2.1 (0.7) | 2.0 (0.7) | 0.157 | 0.225 |
| ACQ score† | 1.5 (1.1) | 1.5 (1.3) | 0.779 | 1.5 (0.8) | 1.9 (1.1) | 0.186 | 0.281 |
| AQLQ score† | 5.8 (0.9) | 5.5 (1.5) | 0.295 | 5.5 (1.1) | 5.5 (1.2) | 0.826 | 0.658 |
| FeNO (ppb)‡ | 27.8 (0.3) | 32.9 (0.3) | 0.241 | 26.4 (0.3) | 29.7 (0.2) | 0.359 | 0.787 |
| Corrected alveolar NO (ppb)* | 1.9 (1.0–2.5) | 1.3 (0.1–3.0) | 0.789 | 2.5 (0.9–3.1) | 2.9 (1.1–3.6) | 0.859 | 0.922 |
| Blood eosinophils (×109/L)* | 0.1 (0.0–0.2) | 0.3 (0.2–0.4) | 0.049 | 0.2 (0.1–0.4) | 0.3 (0.2–0.5) | 0.091 | 0.283 |
*Median (IQR).
†Mean (SD).
‡Geometric mean (log SD).
ACQ, Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 s; NO, nitric oxide.