Guilbert 2006.
| Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: National Institutes of Health and National Jewish Medical and Research Center, USA |
|
| Participants | Setting: 5 clinical centres in the USA Eligible: 456 Randomly assigned: 143 (CFC‐fluticasone); 142 (placebo) Gender (male): 61.5% (CFC‐fluticasone); 62.7% (placebo) Age, years, mean ± SD: fluticasone 3.0 ± 0.6; placebo 3.0 ± 0.6 Inclusion criteria: preschool children with no clinically significant medical disorders apart from wheezing or allergy; high risk for persistence of asthma‐like symptoms according to a positive modified asthma predictive index; had received not more than 4 months of treatment with inhaled corticosteroids before enrolment; asthma symptoms not requiring inhaled corticosteroids during a run‐in month Exclusion criteria: See above Previous regular use of ICS: < 4 months |
|
| Interventions | Test group:
Control group: matching placebo Treatment was given twice daily via MDI with a valved spacer (AeroChamber). Treatment duration was 2 years, followed by a 1‐year washout period |
|
| Outcomes |
Height was measured at every visit with an upright stadiometer (Harpenden, Holtain) by established procedures |
|
| Notes | Adherence to treatment, defined as percentage of days in which a child took the prescribed dose of study medication as measured by an electronic meter. Compliance rate was 74% in the fluticasone group and 69% in the placebo group Use of systemic corticosteroids for exacerbations (number of courses/100 child‐years): fluticasone 57.4 (95% CI 49.0 to 67.3); placebo 89.4 (95% CI 78.3 to 102.2) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated |
| 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 | Unclear risk | Withdrawal rate was 11/143 (7.7%) in the fluticasone group and 12/142 (8.5%) in the placebo 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 |