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

Gelfand 2006 b.

Methods DESIGN: randomised, double‐blind, multi‐centre, placebo‐controlled, parallel‐group clinical study. This comprises 2 identical trials
Participants SYMPTOMATIC PARTICIPANTS
RANDOMLY ASSIGNED: N = 505
INTERVENTION: ICS (ciclesonide 40 μg/d): 252
CONTROL: ICS (ciclesonide 160 μg/d): 253
WITHDRAWALS: reported
AGE: mean (years) (range):
INTERVENTION: ICS (ciclesonide 40 μg/d): 8.14 ± 0.14 (4‐11)
CONTROL: ICS (ciclesonide 160 μg/d): 8.33 ± 0.12 (4‐11)
GENDER: N (male %):
INTERVENTION: ICS (ciclesonide 40 μg/d): 160 (63.5)
CONTROL: ICS (ciclesonide 160 μg/d): 154 (60.9)
ASTHMA SEVERITY: persistent asthma with all severity
ASTHMA DURATION: mean (months) (range):
INTERVENTION: ICS (ciclesonide 40 μg/d): 4.32 ± 0.18 (0.26‐11.26)
CONTROL: ICS (ciclesonide 160 μg/d): 4.38 ± 0.17 (0.53‐12.06)
MEAN (± SD) β2‐AGONIST USE (puffs/d):
INTERVENTION: ICS (ciclesonide 40 μg/d): 1.60
CONTROL: ICS (ciclesonide 160 μg/d): 1.72
DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: placebo
ATOPY (% of participants): not reported
ELIGIBILITY CRITERIA

  • As above


EXCLUSION CRITERIA

  • As above
Interventions PROTOCOL
DURATION

  • Run‐in = 5 to 21 days

  • Intervention = 12 weeks


DEVICE: HFA‐metered‐dose inhaler
DOSE OF ICS

  • INTERVENTION: ciclesonide 40 μg/d

  • CONTROL: ciclesonide 160 μg/d


CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes As above
Notes As above
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information on sequence generation
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