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Azithromycin improves asthma control and reduces exacerbations in kids with poor control, but replication needed
Clinical Question
Does the addition of azithromycin 3 times per week to usual care improve outcomes for children with poorly controlled asthma?
Bottom line
This study reports a dramatic improvement in asthma control and a decrease in exacerbations with azithromycin 3 times per week. The small sample, short duration of the study, and open-label design mean we should interpret these results with caution and look for replication with a larger population and for a longer period (such as a year) to fully assess the harms as well as the benefits. 1b-
Reference
Study design: Randomized controlled trial (nonblinded)
Funding: Self-funded or unfunded
Setting: Outpatient (any)
Synopsis
Azithromycin has anti-inflammatory properties as well as antibacterial effects. The researchers in this study identified 120 children, aged 5 years to 15 years, with an Asthma Control Test (ACT) score of 19 points or less, which is consistent with poor control. (A Childhood Asthma Control Test [CACT] result of 19 or less was used for children younger than 12 years). At baseline, there were some imbalances between groups, so ANCOVA was used to adjust for the imbalance in ACT and CACT scores. Children were randomized to receive usual care plus azithromycin 10 mg per kg 3 times a week or usual care alone in an open-label fashion; it does not appear that outcome assessors were masked to treatment assignment. Usual care included and inhaled corticosteroid with or without a long-acting beta agonist and step-up/step-down therapy. The ACT score increased from 15.8 to 18.3 in the control group, and from 14.8 to 21.7 in the azithromycin group (adjusted change 2.4 vs 6.9 points; P < .001). Using the Global Initiative for Asthma definition of good control — an ACT score of greater than 19 points — children in the azithromycin group were more likely to have good control (69.5% vs 18%; P < .001; number needed to treat = 2). Gastrointestinal and skin adverse effects were uncommon and similar between groups. The median number of exacerbations per patient was lower in the azithromycin group (0 vs 1; P < .001 by the rank sum test; it would have been nice to see the actual number of exacerbations in each group).
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
Azithromycin for asthma control
Seemingly impressive but not ready to jump onto the Azithro ship on the basis for this study. One for the reasons the reviewer points out and two, for an RCT to have baseline differences differences between treatment group (esp in the ACT score which was the primary outcome variable studied) one wonders whether allocation was truly random. Agree study is intriguing enough to merit being repeated with a more robust study design.
Unusual findings
Unusual findings from an antibiotic in childhood asthma
Flawed
This is a flawed study and should not be promoted. Antibiotic overuse is real.
azithro use and asthma in children
3 doses per week may improve asthma treatment but more studies needed
Too good to be true
Definitely needs replication, and a look at side effect profile.