Wolter 2002.
| Methods | Randomised placebo‐controlled trial. | |
| Participants | 60 adult participants. Mean age 27.9 (SD, 6.5). The placebo group contained more men (20/30 versus 9/30), was taller, heavier and had better lung function (FEV1 mean (SD), 62.3 (24.8) versus 50.9 (18.3)). | |
| Interventions | Azithromycin, 250 mg once a day for 3 months versus placebo. | |
| Outcomes | % change in FEV1 (FVC), weight, QoL, inflammatory markers, microbiology, respiratory exacerbations. | |
| Notes | Patients recruited from two adult clinics in Brisbane (first Australian study). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Hospital pharmacy staff, exact method not stated ("randomised prior to commencement of study"). |
| Allocation concealment (selection bias) | Low risk | By hospital pharmacy. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Identical capsules and number, all parties blind. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis performed on primary outcome, others reported per protocol. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Other bias | Unclear risk | Baseline characteristics significantly different between interventions, see above "Participants". |
AB: antibiotic BPI‐ANCA: bactericidal or permeability‐increasing protein CF: cystic fibrosis FEV1: forced expiratory volume at one second FVC: forced vital capacity IPD: individual patient data ITT: intention to treat IV: intravenous MEF: maximum expiratory flow P. aeruginosa: Pseudomonas aeruginosa PEx: pulmonary exacerbation QoL: quality of life Relative change in FEV1: ((Intervention value ‐ Baseline value)*100)/Baseline value S. aureus: Staphylococcal aureus SD: standard deviation TDN: therapeutics development network