6/28/23, 12:07 AM AMAZES Pathway Feedback Search Clinical Topics Home Studies AMAZES AMAZES Disease Disease Asthma Severe asthma phenotypes 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 N = 420 39.0% male 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) https://web.pathway.md/studies/recyN5oij9B6vbPSq 1/2 6/28/23, 12:07 AM AMAZES Pathway Primary outcome Total asthma exacerbations 1.9/ p-y 1.86 1.4/ p-y 1.07 0.9/ p-y 0.5/ p-y Significant decrease 0.0/ p-y Oral azithromycin Placebo 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. Open reference URL https://web.pathway.md/studies/recyN5oij9B6vbPSq 2/2