2. Effect of the intervention: ciclesonide versus budesonide.
| Dose | CIC 160 μg OD versus BUD 400 μg OD | CIC 320 μg OD versus BUD 800 μg OD |
| Dose ratio | 1:2 | 1:2 |
| Study | von Berg 2007 | Vermeulen 2007 |
| Primary outcomes | ||
| Asthma symptoms: asthma symptom score (sum score) | ITT: MD 0.01, 95% CI ‐0.14 to 0.16 PP: MD 0.03, 95% CI ‐0.20 to 0.25 Non‐inferiority acceptance limit = 0.3 |
Median change from baseline (no CIs reported) ITT: CIC: ‐0.07; BUD: ‐0.14 PP: CIC: ‐0.07; BUD: ‐0.14 |
| Asthma symptoms: use of rescue medication (puff/day) | ITT: MD 0.06 puffs/day, 95% CI ‐0.26 to 0.38 | Not assessed |
| Asthma symptoms: % of asthma symptom and rescue medication‐free days | ITT: CIC: mean 73%; BUD: mean 70% No difference between groups |
ITT and PP: CIC: median 84%; BUD: median 85% Lower limit of the between difference was ‐1.4% and above non‐inferiority limit of ‐8% |
| Exacerbations: patients with exacerbations* | ITT: RR 2.71, 95% CI 0.61 to 12.11; Analysis 1.1 | ITT: RR 1.69, 95% CI 0.36 to 8.00; Analysis 1.1 |
| Adverse events: patients with adverse events | Adverse events were reported in 38% of patients in both groups | ITT: RR** 1.44, 95% CI 0.96 to 2.18 |
| Adverse events: change in body height | Mean change from baseline (least square mean) CIC: 1.18 cm; BUD: 0.70 cm |
Not assessed |
| Adverse events: 24‐hour urine cortisol adjusted for creatinine | ITT: 2.99 nmol/mmol creatinine; P < 0.0001, one‐sided (decrease greater in the BUD group) | ITT: significant difference between groups (lower level in BUD group) |
| Secondary outcomes | ||
| Quality of life: PAQLQ(S) | ITT: MD ‐0.11, 95% CI ‐0.12 to 0.10, one‐sided superiority; Analysis 1.2 Non‐inferiority acceptance limits = not provided PP not reported |
ITT: MD (least square mean) 0.01, 95% CI ‐0.14 to 0.16; Analysis 1.2 Non‐inferiority acceptance limit = ‐0.5% PP results were similar |
| Quality of life: PACQLQ | ITT: MD ‐0.08, 95% CI ‐0.27 to 0.11, one‐sided superiority Non‐inferiority acceptance limit not provided PP not reported |
Not assessed |
| Compliance | Not assessed | Not assessed |
| Lung function: FEV1 (L) | ITT: MD (least square means) ‐0.019 L, 95% CI ‐0.059 to 0.022; Analysis 1.3 PP: MD (least square means) ‐0.034 L, 95% CI ‐75 to 10 Non‐inferiority acceptance limit = ‐100 mL |
ITT: MD (least square means) ‐0.03 L, 95% ‐0.14 to 0.8; Analysis 1.3 PP: MD (least square means) ‐0.02 L, 95% CI ‐0.13 to 0.1 Non‐inferiority acceptance limit = ‐150 mL |
| Airway inflammation | Not assessed | Not assessed |
BUD: budesonide; CI: confidence interval; CIC: ciclesonide; ITT: intention to treat analysis; MD: mean difference; OD: once daily; PACQLQ: Pediatric Asthma Caregiver Quality of Life Questionnaire; PAQLQ: Pediatric Asthma Quality of Life Questionnaire; PP: per protocol; RR: risk ratio.
* Exacerbations were defined as an increasing asthma symptoms requiring change or addition of patient's medication other than increasing rescue medication.
** Adverse events that needed treatment, reported in over 2% of patients in CIC or BUD group of safety population (N = 403).