Roux 2003.
Methods | Design: multi‐centre, randomised, open‐label, parallel‐group, controlled trial Sponsor: GlaxoSmithKline |
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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 |
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Interventions | Test group:
Control group:
Fluticasone was given twice daily via Diskus/Accuhaler. Nedocromil sodium was given twice daily via MDI. Treatment duration was 24 months |
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Outcomes |
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 |
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Notes | Treatment compliance was not measured Use of systemic corticosteroids for exacerbations: fluticasone 26%; nedocromil sodium 43% |
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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 |