AMAZES
Trial question
What is the effect of oral azithromycin on asthma exacerbations in patients with uncontrolled persistent asthma despite maintenance treatment?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 420
420 patients (255 female, 165 male)
Inclusion criteria: patients with uncontrolled persistent asthma on medium-to-high dose ICS plus a long-acting bronchodilator
Key exclusion criteria: recent exacerbations, infections, or changes in maintenance medication within 4 weeks, smokers, parenchymal lung disease, including emphysema, hearing impairment or abnormally prolonged QTc interval
Interventions
N=213 oral azithromycin (500 mg thrice weekly for 48 weeks)
N=207 placebo (matched placebo thrice weekly for 48 weeks)
Primary outcome
Total asthma exacerbations
1.07
1.86
1.9/ p-y
1.4/ p-y
0.9/ p-y
0.5/ p-y
0.0/ p-y
Oral azithromycin
Placebo
Significant decrease ▼
Significant decrease in total asthma exacerbations (1.07/ p-y vs. 1.86/ p-y; IRR 0.59, 95% CI 0.47 to 0.74)
Secondary outcomes
Significant decrease in the percentage of patients experiencing at least 1 asthma exacerbation (44% vs. 61%; RR= 0.72, 95% CI 0.36 to 1.08)
Safety outcomes
Significant differences in diarrhea (34% vs. 19%, p = 0.001).
Conclusion
In patients with uncontrolled persistent asthma on medium-to-high dose ICS plus a long-acting bronchodilator, oral azithromycin was superior to placebo with respect to total asthma exacerbations.
Reference
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.
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