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

Peden 1998 b.

Methods DESIGN: randomised, double‐blind, double‐dummy, placebo‐controlled, parallel‐group study; multi‐centre
Participants SYMPTOMATIC PARTICIPANTS
RANDOMLY ASSIGNED: N = 174
INTERVENTION: ICS (fluticasone 100 μg/d): 91
CONTROL: ICS (fluticasone 200 μg/d): 83
WITHDRAWALS: reported
AGE: median (years) (range): 4 to 11 years
INTERVENTION: ICS (fluticasone 100 μg/d): not reported
CONTROL: ICS (fluticasone 200 μg/d): not reported
GENDER: N (male %):
INTERVENTION: ICS (fluticasone 100 μg/d): 50 (55)
CONTROL: ICS (fluticasone 200 μg/d): 50 (60)
ASTHMA SEVERITY: mild to moderate persistent asthma
ASTHMA DURATION: median (months) (range): not reported
MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported
DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: not reported
ATOPY (% of participants): not reported
ELIGIBILITY CRITERIA
  • As above


EXCLUSION CRITERIA
  • As above

Interventions PROTOCOL
DURATION
  • Run‐in = 2 weeks

  • Intervention = 12 weeks


DEVICE: Diskus or Diskhaler
DOSE OF ICS
  • INTERVENTION: fluticasone 100 μg/d

  • CONTROL: fluticasone 200 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