| Methods |
Double‐blind placebo‐controlled study from 10 German and 1 Swiss centre. |
| Participants |
38/40 screened patients were randomised. Mean age (SD), 24.8 years (10.0). |
| Interventions |
Azithromycin (once a week, dose from 500‐1250 mg depending on weight) versus placebo for 8 weeks, following a course of IV antibiotic treatment. |
| Outcomes |
Change in pulmonary function tests from baseline, adverse events, change in QoL domains, inflammatory markers in sputum. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Allocation was undertaken centrally using a computer‐generated sequence. |
| Allocation concealment (selection bias) |
Low risk |
Allocation was organised centrally with support from the Clinical Trials Officer. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Indentical look and taste of tablets. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
A clear ITT analysis of the primary outcome. Some secondary outcomes analysed per protocol. |
| Selective reporting (reporting bias) |
High risk |
All measured outcomes reported, some provided by authors directly (QoL). Data from outcomes beyond 8 weeks not reported. |
| Other bias |
High risk |
Duration of study was shortened after commencement of study and data only reported for 8 weeks (correspondence with Prof Steinkamp). |
