Giorgi 1998.

Methods	DESIGN: randomised, open‐label, multi‐centre, parallel‐group clinical study
Participants	CHILDREN WITH MILD ASTHMA RANDOMLY ASSIGNED: N = 29 INTERVENTION: ICS (flunisolide 600 μg/d): 15 CONTROL: ICS (flunisolide 1200 μg/d): 14 WITHDRAWALS: reported AGE: mean (years) (range): INTERVENTION: ICS (flunisolide 600 μg/d) 8.6 (6‐11) CONTROL: ICS (flunisolide 1200 μg/d) 8.5 (7‐10) GENDER: N (male %): INTERVENTION: ICS (flunisolide 600 μg/d) 11 (73%) CONTROL: ICS (flunisolide 1200 μg/d) 9 (64%) ASTHMA SEVERITY: mild asthma ASTHMA DURATION: mean (months) (range): INTERVENTION: ICS (flunisolide 600 μg/d) 4.8 (3‐7) CONTROL: ICS (flunisolide 1200 μg/d) 4.9 (3‐7) MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: placebo ATOPY N (% of participants): reported INTERVENTION: ICS (flunisolide 600 μg/d) 9 (60%) CONTROL: ICS (flunisolide 1200 μg/d) 10 (71%) ELIGIBILITY CRITERIA Prepubertal children with mild asthma who used inhaled beta stimulants regularly were eligible for participation in the study EXCLUSION CRITERIA Patients with any other pulmonary disease, serious concomitant disease or a history of bone fractures were excluded from participation
Interventions	PROTOCOL DURATION Run‐in = 2 weeks. Intervention = 12 weeks DEVICE: jet nebulisers (Soffio Nuovo, Markos, Monza, Italy) DOSE OF ICS INTERVENTION: flunisolide 600 μg/d CONTROL: flunisolide 1200 μg/d CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes	ANALYSIS: no intention‐to‐treat analysis OUTCOMES: reported at 12 weeks. Outcomes were measured at 2, 3 and 4 months GROWTH MEARSUREMENT TECHNIQUE: not reported PULMONARY FUNCTION TESTS: not measured FUNCTIONAL STATUS: not measured BIOMARKERS OC BALP PICP ICTP ADVERSE EVENTS: not reported WITHDRAWALS: reported
Notes	PUBLICATION: full paper (1998) FUNDING: funded by Valeas Pharmaceuticals CONFIRMATION OF METHODOLOGY: not received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	This trial was randomised but the technique of randomisation was not described
Allocation concealment (selection bias)	High risk	No allocation concealment used in the study
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	No measures reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Withdrawals per group not reported
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	High risk	This was an open‐label study and the primary outcome was not specified clearly