Pedersen 2010.
Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Nycomed |
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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 |
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Interventions | Test group:
Control group: matching placebo Treatment was given once daily via HFA‐MDI (2 subgroups: with and without use of a spacer) for 12 weeks |
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Outcomes |
Height was measured at start and end of treatment period using a stadiometer |
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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 |