Role of azithromycin as an add-on therapy in children with acute asthma exacerbation: A randomized controlled trial

Background: Asthma, a chronic inflammatory airway disease, commonly affects children worldwide. Acute asthma exacerbations significantly impact children's health, growth, and quality of life, straining families. To improve symptom relief and quality of life, new treatment options are needed. Objective: This study aimed to determine the effectiveness of azithromycin (AZI) as an add-on therapy to standard treatment in children aged 5-14 years experiencing acute asthma exacerbation. Study Design: A prospective, open-label, randomized controlled trial was conducted. Participants: Two hundred children presenting with acute asthma exacerbations were enrolled and divided into two groups (n = 100 each) using computer-generated randomization. Intervention: The intervention group received oral AZI (10 mg/kg body weight once daily for 3 days) alongside standard therapy (inhaled β2-agonist, inhaled and/or systemic corticosteroids). The control group received standard therapy alone. Outcomes: Both groups were assessed on day 4 for the proportion of patients experiencing relief from respiratory symptoms (cough, noisy breathing, chest discomfort, fast breathing, difficulty breathing) and any side effects. Quality of life was assessed using the MINIPQLQ score on day 14. Results: The AZI group showed significantly better early symptom relief (cough, chest discomfort, noisy breathing, fast breathing, and difficulty breathing) on day 4 compared to the control group. Additionally, the AZI group demonstrated improved quality of life as measured by the MINIPQLQ score on day 14. No significant differences in lung function improvement (peak expiratory flow rate) or side effects were observed between the groups. Conclusion: The study suggests that adding AZI to standard treatment for children with acute asthma exacerbation leads to earlier symptom relief and improved quality of life without significant side effects.