Pedersen 2010 b.
Methods | Same as above | |
Participants | SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = ANALYSED PARTICIPANTS: N = 462 INTERVENTION: ICS (ciclesonide 40 μg/d): 305 CONTROL: ICS (ciclesonide 160 μg/d): 310 WITHDRAWALS: reported AGE: median (years) (range): INTERVENTION: ICS (ciclesonide 40 μg/d): 8.0 (6‐11) CONTROL: ICS (ciclesonide 160 μg/d): 9.0 (6‐11) GENDER: N (male %): INTERVENTION: ICS (ciclesonide 40 μg/d): 210 (68.9%) CONTROL: ICS (ciclesonide 160 μg/d): 218 (70.3%) ASTHMA SEVERITY: persistent asthma but severity not reported ASTHMA DURATION: median (months) (range): INTERVENTION: ICS (ciclesonide 40 μg/d): 41.4 (6‐127) CONTROL: ICS (ciclesonide 160 μg/d): 41.7 (6‐129) MEAN (± SD) β2‐AGONIST USE (puffs/d): median (months) (range) INTERVENTION: ICS (ciclesonide 40 μg/d): 1.43 (0.00‐7.86) CONTROL: ICS (ciclesonide 160 μg/d): 1.57 (0.00‐7.71) DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: placebo ATOPY (% of participants): not reported ELIGIBILITY CRITERIA
EXCLUSION CRITERIA
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Interventions | PROTOCOL DURATION
DEVICE: metered‐dose inhaler with or without spacer DOSE OF ICS
CRITERIA FOR WITHDRAWAL FROM STUDY: reported |
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Outcomes | Same as above | |
Notes | Same as above | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using a computer random number generator |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Study protocol not available but published reports include all expected outcomes, including those that were prespecified |
Other bias | Low risk | Study apparently free of other sources of bias |