de Benedictis 2001.

Methods	Setting: Multicentre trial Design: parallel group Length of intervention period: 52 weeks Randomisation: PACT (computer package for GSK) Allocation concealment: Adequate Masking: double‐blind Excluded: Yes (post run‐in) Withdrawals: Stated Jadad score: 5
Participants	343 children randomised. Mean age: FP: 7.6 (SD 1.7); BDP: 7.6 (SD 2.0). No baseline data given for lung function, current treatment or symptoms. Inclusion criteria: Boys aged 4‐11, girls aged 4‐9 with sexual maturity Tanner rating stage 1; requirement of FP 100‐200 mcg/d, or BDP 200‐500 mcg/d at least previous 8 weeks, at constant dose for at least 4 weeks before run‐in period Exclusion criteria: Intermittent asthma; disoders that could affect growth; OCS/parnteral CS rx; admission to hospital in last 4 weeks before run‐in phase with respiratory disease.
Interventions	FP: 200 mcg 2xdaily (400 mcg/d) BDP: 200 mcg 2xdaily (400 mcg/d) Delivery device: Diskhaler DPI
Outcomes	PEF (am and pm); FEV1; symptoms; rescue medication; growth
Notes	Unpublished data supplied by GSK 140904
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	See Appendix 2
Allocation concealment?	Low risk	See Appendix 2
Blinding? All outcomes	Low risk	Identical inhaler devices