A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation

Background We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. Methods We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. Results 48 patients were rand...

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Bibliographic Details
Published in:	Thorax 2015-05, Vol.70 (5), p.442-450
Main Authors:	Corris, Paul A, Ryan, Victoria A, Small, Therese, Lordan, James, Fisher, Andrew J, Meachery, Gerard, Johnson, Gail, Ward, Chris
Format:	Article
Language:	eng
Subjects:	Adult Anti-Bacterial Agents - therapeutic use Azithromycin - therapeutic use Bronchiolitis Obliterans - diagnosis Bronchiolitis Obliterans - drug therapy Bronchiolitis Obliterans - etiology Clinical medicine Double-Blind Method Drug dosages Female Forced Expiratory Volume Humans Lung Transplantation Lung Transplantation - adverse effects Male Middle Aged Mortality Neutrophils Studies Syndrome Transplants & implants Treatment Outcome
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Summary:	Background We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. Methods We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. Results 48 patients were randomised; (25 azithromycin, 23 placebo). It was established, post randomisation that two did not have BOS. 46 patients were analysed as intention to treat (ITT) with 33 ‘Completers’. ITT analysis included placebo patients treated with open-label azithromycin after study withdrawal. Outcome The ITT analysis (n=46, 177 observations) estimated mean difference in FEV1 between treatments (azithromycin minus placebo) was 0.035 L, with a 95% CI of −0.112 L to 0.182 L (p=0.6). Five withdrawals, who were identified at the end of the study as having been randomised to placebo (four with rapid loss in FEV1, one withdrawn consent) had received rescue open-label azithromycin, with improvement in subsequent FEV1 at 12 weeks. Study Completers showed an estimated mean difference in FEV1 between treatment groups (azithromycin minus placebo) of 0.278 L, with 95% CI for the mean difference: 0.170 L to 0.386 L (p=
ISSN:	0040-6376 1468-3296