“Azithromycin for acute exacerbations of asthma: The AZALEA randomized clinical trial,” JAMA IM, 2016, United Kingdom
Question: Does azithromycin improve outcomes for patients with acute asthma exacerbations?
Study Type: Multicenter, double-blind, placebo-controlled randomized trial
Study Population: Adults with a documented history of asthma who required IV or oral steroids for an acute asthma exacerbation were eligible. Notable exclusion criteria included the use of oral or intravenous corticosteroids within the previous 28 days and need for intensive care unit admission.
Study Groups: Patients were randomized to receive azithromycin 500mg daily or placebo for 3 days.
Primary Outcome: Diary card summary symptom score at day 10
Results: Of the 4,500 patients screened, 45% were excluded because they had already received antibiotics. 199 patients were randomized. Asthma symptom scores measured at day 10 did not differ between the two groups. Similarly, the addition of azithromycin did not improve quality-of-life scores, lung function measurements, or time to 50% reduction in symptom score.
Caveats: Study did not meet enrollment goal and was underpowered, investigators enrolled a select group of patients that treating clinicians felt would not benefit from antibiotic therapy (the 55% of patients not excluded for already receiving abx) perhaps skewing the trial toward a negative result.
Take-home Point: Azithromycin does not improve outcomes for patients with acute asthma exacerbations. The trial also shows that abx are still widely prescribed for asthma exacerbations despite not being supported by guidelines or evidence.