Azithromycin 500 mg three times per week for 48 weeks
Control
Placebo
Population
420 adults with symptomatic asthma despite inhaled steroid and long-acting bronchodilator
Inclusion criteria
Aged 18 or over, symptomatic asthma despite inhaled corticosteroid and long-acting bronchodilator, no hearing impairment and no prolongation of the corrected QT interval.
Follow-up
48 weeks
Primary endpoint
Rate of total (severe and moderate) asthma exacerbations, and asthma-related quality of life
Result
Exacerbations 1.07 per patient-year (95% CI 0.85 to 1.29) with azithromycin versus 1.86 (1.54 to 2.18) with placebo — incidence rate ratio 0.59 (0.47 to 0.74), p<0.0001. At least one exacerbation occurred in 44% versus 61% (p<0.0001). Quality of life improved by 0.36 units (0.21 to 0.52, p=0.001). Diarrhoea affected 34% versus 19% (p=0.001).
Secondary endpoints
Proportion exacerbating, asthma-related quality of life, adverse effects
Adults with persistent symptomatic asthma experience fewer asthma exacerbations and improved quality of life when treated with oral azithromycin for 48 weeks. Azithromycin might be a useful add-on therapy in persistent asthma.
The trial authors, in the published abstract
How it has aged
The strongest evidence for macrolides in asthma, and it works across eosinophilic and non-eosinophilic disease — which makes it one of the few options for the neutrophilic patient no biologic will help. Its enrolment criteria are the practical caveat: hearing and QT interval were screened, and should be in practice too, as in MACRO for COPD.
Publications
Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial
Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial. Lancet 2017 Aug 12;390(10095):659-668.
41% reduction in the rate of moderate and severe exacerbations
Proportion having any exacerbation fell from 61% to 44%
Clinically meaningful gain in asthma quality of life