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
EXCLUSION CRITERIA
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Interventions | PROTOCOL DURATION
DEVICE: Diskus or Diskhaler DOSE OF ICS
CRITERIA FOR WITHDRAWAL FROM STUDY: reported |
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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 |