| Methods |
Multicentre randomised placebo‐controlled trial. |
| Participants |
185 participants: adults and children with CF (> 6 years) with chronic P. aeruginosa chest infection (> 1 year) and an FEV1 >30% predicted. |
| Interventions |
Azithromycin, 500 mg (250 mg if weight <40 kg) 3 days a week versus placebo. |
| Outcomes |
Primary: relative change in FEV1 (% predicted).
Secondary: adverse events, self‐reported symptoms, audiology and laboratory tests, respiratory cultures, relative change in FVC (% predicted), body weight, PEx (number and time to), hospitalisation rate, use of non‐quinolone antibiotics, inflammatory markers, and QoL. |
| Notes |
First North American Study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
By CF TDN Co‐ordinating Centre. Randomisation included a valid allocation strategy to ensure equivalence between placebo and intervention with respect to weight, respiratory function and site of study. |
| Allocation concealment (selection bias) |
Low risk |
Centralised secure randomisation system at the co‐ordinating centre. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
All study personnel and participants. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Clear ITT analysis of primary outcome. |
| Selective reporting (reporting bias) |
Low risk |
Outcomes clearly reported. Subsequent subgroup analysis published separately. |
| Other bias |
Low risk |
None identified. |
