A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation.
Corris PA, Ryan VA, et al.Thorax 2015;70(5):442-50.
Aims
To evaluate the effectiveness of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation.
Interventions
Azithromycin (250 mg on alternate days for 12 weeks) or placebo
Participants
The primary outcome was change in forced expiratory volume (FEV) from baseline to 12 weeks. Secondary outcome measures were change forced vital capacity (FVC) from baseline and change in bronchoalveolar lavage neutrophils.
Outcomes
The primary outcome was change in forced expiratory volume (FEV) from baseline to 12 weeks. Secondary outcome measures were change forced vital capacity (FVC) from baseline and change in bronchoalveolar lavage neutrophils.
Follow-up
12 weeks
CET Conclusions
According to the authors this is the first randomised controlled trial evaluating the effectiveness of azithromycin to improve lung function in lung transplant recipients with bronchiolitis obliterans syndrome (BOS). Using a double-blinded design, 48 lung transplant recipients were allocated to azithromycin for 12 weeks or placebo. Sample size calculations indicated that 64 patients were needed (although no details were provided) but only 48 patients were randomised. The effect of azithromycin on the primary outcome forced expiratory volume (FEV1) was not significant however 39% patients in the azithromycin group experienced >10% gain in FEV¬¬1¬ from baseline versus none in the placebo group. The per protocol analysis of only 33 patients who completed 12 weeks azithromycin did show a significant difference in FEV¬¬1¬. From a methodological point a few, the author’s conclusion that azithromycin improved lung function for lung transplant recipients seems premature on the basis of this underpowered analysis.
Data analysis
Per protocol analysis
Trial registration
EU-CTR, 2006-000485-36/GB.