Long-term effect of azithromycin in bronchiolitis obliterans syndrome.Gan, C. T., et al.
BMJ open respiratory research 2019; 6(1): e000465.
The aim of this study was to perform a post hoc analysis to evaluate the long-term effect of azithromycin on forced expiratory volume (FEV1), bronchiolitis obliterans syndrome (BOS) progression and survival .
Patients were randomized to either the azithromycin group or the placebo group.
46 lung transplant recipients.
The outcomes of interest were the evolution of FEV1 litres, progression of BOS and overall survival.
At least 6 years
This report includes longer term follow up of a prior randomised controlled trial (Corris et al, 2015). In the initial, blinded RCT, lung transplant patients were randomised to placebo or azithromycin as treatment for Bronchiolitis Obliterans Syndrome (BOS) after lung transplantation. The results of the 3-month study showed that azithromycin improved FEV1 in the setting of BOS. This conclusion was in part contributed to by the fact that 5 study withdrawals from the placebo arm were given rescue open-label azithromycin. The patients from both arms of the study were then converted to open-label azithromycin and followed up for a further 6 years, and these results are reported in this most recent paper. The authors have kept an intention to treat analysis for this most recent report despite 40-50% deaths in both arms. This study found that the initial therapy for 3 months (placebo or azithromycin) did not impact on the long term outcome and the lung function of patients starting on placebo stabilised after receiving azithromycin and progression free survival was not different between the groups. Nor did BOS severity affect survival. There was no power calculation presented in this paper though for these post hoc analyses.
EU-CTR, 2006- 000485-36/GB