Clement 2006.
| Methods | Randomised, multicentre, double‐blind, placebo‐controlled trial. | |
| Participants | 82 young people with CF (6‐21 years, mean age 11.0 years, SD 3.3 years), 40 in azithromycin group, 42 in placebo group. 35 in treatment group and 37 in placebo group completed trial. FEV1 >40% predicted. |
|
| Interventions | Azithromycin 250 mg tablet 3 times per week (>40 kg, 500 mg) versus placebo. | |
| Outcomes | Relative change in FEV1 & FVC % predicted, number of pulmonary exacerbations, additional antibiotic treatment (oral and IV), lung microbiology and adverse events. | |
| Notes | French study. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Centralised secure randomisation department". |
| Allocation concealment (selection bias) | Low risk | Centralised, study number assigned by interactive voice response system, study kits distributed by chief pharmacist in each centre. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Identically packaged, all participants and investigators blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | A complete ITT analysis undertaken on primary outcome and pulmonary exacerbation data. Some per protocol analysis on other outcomes. |
| Selective reporting (reporting bias) | Unclear risk | Some data at intermediate time points not reported (requested from authors, who kindly provided some IPD, although intermediate time points not available). |
| Other bias | Low risk | None identified. |