Roux 2003.

Methods	Design: multi‐centre, randomised, open‐label, parallel‐group, controlled trial Sponsor: GlaxoSmithKline
Participants	Setting: 52 specialist clinics in France Eligible: 207 Randomly assigned: 87 (fluticasone); 87 (nedocromil sodium) Analysed: 87 (fluticasone); 87 (nedocromil sodium) Gender (male): 74.7% Age, years, mean ± SD: fluticasone 9.1 ± 2.5: nedocromil 9.4 ± 2.4 Inclusion criteria: children 6‐14 years of age; weighed ≥ 13 kg, with persistent asthma defined as exacerbations occurring at least once a week but less often than daily, or chronic symptoms requiring daily treatment with a short‐acting β2‐agonist Exclusion criteria: treatment during the previous month with an oral, inhaled or intranasal corticosteroid, a chromone theophylline or a long‐acting β2‐agonist; uncontrolled serious concurrent disease Previous regular use of ICS: not allowed
Interventions	Test group: Fluticasone, 200 μg/d Control group: Nedocromil sodium, 4 mg/d Fluticasone was given twice daily via Diskus/Accuhaler. Nedocromil sodium was given twice daily via MDI. Treatment duration was 24 months
Outcomes	Linear growth velocity (cm/y) Change in height over time (cm) Bone safety: dual‐energy x‐ray absorptiometry (DXA) Height was measured at the end of the run‐in period and at months 12 and 24, using the standard methods in place at each centre
Notes	Treatment compliance was not measured Use of systemic corticosteroids for exacerbations: fluticasone 26%; nedocromil sodium 43%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Balanced, block randomisation with gender stratification
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label
Incomplete outcome data (attrition bias) All outcomes	High risk	Withdrawal rate was 13/87 (14.9%) in the fluticasone group and 28/87 (32.2%) in the nedocromil sodium group
Selective reporting (reporting bias)	Low risk	Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified
Other bias	Low risk	Study appears to be free of other sources of bias