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

Background: Azithromycin has immunomodulatory actions, and its beneficial effects have been demonstrated in asthmatic adults. Data on children are limited.

Research Question: Does the addition of oral azithromycin to standard therapy in children with poorly controlled asthma improve asthma control compared with standard treatment alone?

Study Design And Methods: This open-label randomized controlled trial included children (5-15 years of age) with poorly controlled asthma defined by Asthma Control Test (ACT) and Childhood Asthma Control Test (CACT) score of ≤ 19. They were randomized to receive azithromycin (10 mg/kg) three times weekly for 3 months along with standard treatment or standard treatment alone. The primary outcome was the ACT and CACT scores at 3 months. Secondary outcomes were asthma control according to Global Initiative for Asthma (GINA) guidelines, the number of exacerbations, change in spirometry parameters, change in fractional exhaled nitric oxide (Feno) level, positive throat swab results, and side effects.

Results: The trial included 120 children (89 boys; 60 in each group). The mean ± SD age was 9.9 ± 3 years. The baseline parameters were similar between the groups. Mean ± SD ACT and CACT scores (available for 115 children) at 3 months of intervention were 21.71 ± 2.17 vs 18.33 ± 2.19 (P < .001) in the azithromycin and control groups, respectively. The numbers of children with well-controlled asthma according to GINA guidelines were 41 of 56 vs 10 of 56 in the azithromycin and control groups, respectively (P < .001). The median number of exacerbations requiring emergency visit and steroid use were fewer in the azithromycin group: 0 (interquartile range [IQR], 3) vs 1 [IQR, 6]; P < .001). No difference was found in Feno level, spirometry parameters, positive throat swab results, and adverse effects between the groups.

Interpretation: The use of azithromycin in children with poorly controlled asthma resulted in improved asthma control and reduced exacerbations.

Trial Registry: Clinical Trials Registry - India; No.: CTRI/2019/06/019727; URL: www.ctri.nic.in.