Bisgaard 2004.
| Methods | Design: multi‐centre, randomised, open‐label, parallel‐group, controlled trial Sponsor: GlaxoSmithKline |
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| Participants | Setting: multi‐centre, Bulgaria (13%), Czech Republic (8%), Croatia (5%), Hungary (12%), Israel (4%), New Zealand (4%), Poland (16%), Russia (20%), Slovakia (9%) and South Africa (10%) Eligible: 668 Randomly assigned: 471 (HFA‐fluticasone 100 μg); 154 (sodium cromoglycate 5 mg) Analysed: 381 (HFA‐fluticasone 100 μg); 122 (sodium cromoglycate 5 mg) Gender (male): 64% (fluticasone); 71% (cromoglycate) Age, months, mean (range): fluticasone 31.1 (11‐47); SCG 30.7 (11‐47) Inclusion criteria: children aged 12‐47 months with documented history of recurrent cough or wheeze and between 5th and 95th centiles for height and weight on growth charts provided by the Child Growth Foundation, London, UK Exclusion criteria: had received systemic corticosteroid therapy for > 5 days within 8 weeks or ICS at doses > FP 100 mcg/d or other ICS of 200 mcg/d within 4 weeks of visit 1; hospitalised or altered medication within 4 weeks of visit 1 or hospitalised on > 2 occasions for recurrent wheeze within 12 months of visit 1; systemic disease likely to affect growth; low birth weight (< 1.5 kg) or born before 32 weeks’ gestation Previous regular use of ICS: 36% of participants |
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| Interventions | Test group: HFA‐fluticasone, 200 μg/d Control group: sodium cromoglycate, 20 mg/d Fluticasone was given twice daily via HFA‐MDI with Babyhaler, and cromoglycate was given 4 times daily via MDI with Nebuhaler. Treatment duration was 52 weeks |
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| Outcomes |
Participant height and/or length was measured at each visit in triplicate by the same observer (between 6:00 AM and 10:00 AM) using a calibrated stadiometer and/or an infantometer |
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| Notes | No formal assessment of treatment compliance was made. Compliance rate was > 90% according to participant's diary, in which use of prescribed medications was recorded Use of systemic corticosteroids for exacerbations: fluticasone 6%; sodium cromoglycate 12% |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated, randomised schedule |
| 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 19% in the fluticasone group and 21% in the cromoglycate 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 |