Saiman 2010.
| Methods | Multi‐centre placebo‐controlled parallel design. | |
| Participants | Young CF patients (6‐18 years) without chronic P. aeruginosa airway infection (clear (2 or more cultures) for > 12 months) | |
| Interventions | Azithromycin (250 mg 3 times a week, increased to 500, if weight >36 kg) versus placebo; for 6 months. | |
| Outcomes | Primary: relative change in FEV1 from baseline. Secondary: respiratory exacerbations; treatment requirements; and adverse events. Acquisition of resistant bacteria in respiratory culture. Authors contacted for full data on nutritional outcomes. |
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| Notes | Second North American study. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | University of South Florida generated assignments via secure centralized randomisation system. |
| Allocation concealment (selection bias) | Low risk | Data co‐ordinating centre distributed blinded study drug kits. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Identically packaged tablets. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Modified ITT analysis (3 patients in placebo arm did not receive study drug and were removed) of primary outcome and most others. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Other bias | Low risk | Very clearly reported study. |