| Methods |
Multicentre parallel RCT comparing 2 dosing regimens (daily versus weekly) of azithromycin. |
| Participants |
208 CF patients (6‐58 years). |
| Interventions |
250 mg daily versus 1200 mg weekly doses of azithromycin. |
| Outcomes |
Change in FEV1 (%) at 1,3 and 6 months from baseline. Also time to PEx, adverse effects, days in hospital, QoL, changes in inflammatory markers, acquisition of azithromycin resistant S. aureus. |
| Notes |
Australian study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Microsoft Excel program used by Mater Hospital Pharmacy to generate randomisation schedule. |
| Allocation concealment (selection bias) |
Low risk |
By hospital pharmacy staff (code A or B seen by them and then removed prior to allocation). |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Identical capsules, all parties involved were blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
A clear ITT analysis of the primary outcome and time to first exacerbation. |
| Selective reporting (reporting bias) |
Low risk |
Some data requested from authors (QoL, relative change in FEV1 and weight z scores). |
| Other bias |
Low risk |
None identified. |
