Pedersen 2010.

Methods	Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Nycomed
Participants	Setting: 110 sites in Bulgaria, Germany, Hungary, Poland, Romania, Russia, South Africa, Spain and Ukraine Eligible: 1335 Randomly assigned: 305 (ciclesonide 50 μg); 312 (ciclesonide 100 μg); 313 (ciclesonide 200 μg); 150 (placebo) Analysed: 255 (ciclesonide 50 μg); 255 (ciclesonide 100 μg); 255 (ciclesonide 200 μg); 110 (placebo) Gender (male): 65.8% Age, years, median (range): CIC40 8.0 (6‐11); CIC80 8.0 (6‐11); CIC160 9.0 (6‐11); placebo 8.0 (6‐11) Inclusion criteria: children 6‐11 years of age with persistent asthma for ≥ 6 months; able to perform reproducible lung function tests and have an acceptable MDI inhalation technique; mean PEF value (over last week) of 40%‐90% of predicted value, as well as FEV1 reversibility ≥ 12% predicted after inhalation of 200‐400 mg salbutamol at the end of the run‐in period Exclusion criteria: history of near fatal asthma; respiratory tract infection or asthma exacerbation within the past 30 days; 2 or more inpatient hospitalisations for asthma in the previous year; use of systemic glucocorticosteroids within 30 days before study entry or for > 60 days in the previous 2 years Previous regular use of ICS: ranged from 64.2%‐69.9% among treatment groups
Interventions	Test group: Ciclesonide, 50 μg/d Ciclesonide, 100 μg/d Ciclesonide, 200 μg/d Control group: matching placebo Treatment was given once daily via HFA‐MDI (2 subgroups: with and without use of a spacer) for 12 weeks
Outcomes	Morning PEF Percentage of days with asthma control Mean change in FEV1 Change in asthma symptom score (points/d) Change in use of rescue medication (puffs/d) Change in quality of life questionnaire Urinary cortisol adjusted for creatinine Linea growth velocity (mm/wk) Height was measured at start and end of treatment period using a stadiometer
Notes	Treatment compliance was not formally monitored. Participants and/or caregivers were told to report in their diaries deviations from intended treatment schedule Compliance rate was not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation scheme
Allocation concealment (selection bias)	Unclear risk	No details provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Use of matching placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Use of matching placebo
Incomplete outcome data (attrition bias) All outcomes	Low risk	No withdrawals reported
Selective reporting (reporting bias)	Low risk	Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified
Other bias	Unclear risk	Method of height measure not reported