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. 2014 Jul 16;2014(7):CD009878. doi: 10.1002/14651858.CD009878.pub2

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
  • Same as above


EXCLUSION CRITERIA
  • Same as above

Interventions PROTOCOL
DURATION
  • Run‐in = 2 to 4 weeks

  • Intervention = 12 weeks


DEVICE: metered‐dose inhaler with or without spacer
DOSE OF ICS
  • INTERVENTION: ciclesonide 40 μg/d

  • CONTROL: ciclesonide 160 μg/d


CRITERIA FOR WITHDRAWAL FROM STUDY: reported
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