Azithromycin for Poorly Controlled Asthma in Children: A Randomized Controlled Trial

Area of Science:

• Pediatric Pulmonology
• Clinical Immunology
• Pharmacology

Background:

• Azithromycin exhibits immunomodulatory properties with known benefits in adult asthma.
• Limited data exist regarding azithromycin's efficacy in managing pediatric asthma.

Purpose of the Study:

• To investigate if oral azithromycin improves asthma control in children with poorly controlled asthma when added to standard therapy.
• To compare asthma control, exacerbations, and relevant clinical markers between azithromycin plus standard therapy and standard therapy alone.

Main Methods:

• An open-label randomized controlled trial involving 120 children (5-15 years) with poorly controlled asthma (Asthma Control Test/Childhood Asthma Control Test score ≤ 19).
• Participants received either azithromycin (10 mg/kg) thrice weekly for 3 months plus standard treatment or standard treatment alone.
• Primary outcome: change in ACT/CACT scores at 3 months; secondary outcomes included GINA guideline adherence, exacerbation rates, spirometry, FENO levels, and side effects.

Main Results:

• Azithromycin group showed significantly higher ACT/CACT scores (21.71 vs 18.33, P < .001) and better GINA-defined asthma control (41/56 vs 10/56, P < .001) at 3 months.
• The azithromycin group experienced fewer exacerbations requiring emergency visits and steroid use (median 0 vs 1, P < .001).
• No significant differences were observed in FENO levels, spirometry, or adverse events between groups.

Conclusions:

• Oral azithromycin, when added to standard care, effectively improves asthma control in children with poorly controlled asthma.
• Azithromycin treatment leads to a significant reduction in asthma exacerbations in this pediatric population.
• Azithromycin represents a promising therapeutic addition for managing difficult-to-control pediatric asthma.