Wasserman 2006.
Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, controlled trial Sponsor: GlaxoSmithKline Inc |
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Participants | Setting: 77 study sites in the USA Eligible: 493 Randomly assigned: 111 (CFC‐fluticasone 50 μg); 108 (CFC‐fluticasone 100 μg); 113 (placebo) Analysed: 111 (CFC‐fluticasone 50 μg); 108 (CFC‐fluticasone 100 μg); 113 (placebo) Gender (male): 61.3% Age, months, mean (range): 35.6 (24–47) Inclusion criteria: children 24‐47 months of age; at least 2 exacerbations in the year before screening; regular maintenance therapy for asthma required during the 6 weeks before screening and/or short‐acting β‐agonist therapy for relief of respiratory symptoms at least twice weekly during the 3 weeks before screening Exclusion criteria: history of life‐threatening asthma; upper or lower respiratory tract infection; systemic or moderate to high doses of inhaled corticosteroids within 8 weeks; more than 2 courses of systemic corticosteroids during the previous 6 months; an investigational drug within 30 days of screening Previous regular use of ICS: 24% in the fluticasone 50 group; 29% in the fluticasone 100 group; 35% in the placebo group |
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Interventions | Test group:
Control group: matching placebo All drugs were given twice daily via CFC‐MDI with a valved holding chamber. Treatment duration was 12 weeks |
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Outcomes |
Height was measured in triplicate at approximately the same time of day using a calibrated stadiometer at each visit |
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Notes | Treatment compliance was not mentioned | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was stratified by age |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of matching placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Use of matching placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawal rate was 18/219 (8.2%) in the fluticasone group and 18/113 (15.9%) in the placebo group |
Selective reporting (reporting bias) | Low risk | Study protocol is not available, but the published reports include all expected outcomes, including those that were pre‐specified |
Other bias | Low risk | Study appears to be free of other sources of bias |
BDP: budesonide dipropionate.
BUD: budesonide.
CFC: chlorofluorocarbon.
CIC: ciclesonide.
DPI: dry powder inhaler.
DSCG: disodium cromoglycate
DXA: dual‐energy x‐ray absorptiometry.
FENO: fractional exhaled nitric oxide.
FEV1: forced expiratory volume in one second.
FP: fluticasone propionate.
HFA: hydrofluoroalkane.
HPA: hypothalamic‐pituitary‐adrenal.
ICS: inhaled corticosteroids.
MDI: metered‐dose inhaler.
PC20: 20%.
PEF: peak expiratory flow.
SCG: sodium cromoglycate.
SD: standard deviation.
SDS: standard deviation score.
SE: standard error.