Effect of inhaled corticosteroid with oral montelukast and levocetirizine in asthma: A population-based study

INTRODUCTION: Asthma is a chronic disease that requires careful management, and its exacerbations can be life-threatening. The aim of this study was to ascertain whether inhaled corticosteroids (ICS)-containing inhaler in combination with oral montelukast and levocetirizine could lessen the exacerbation of asthma in comparison to inhaler alone. MATERIALS AND METHODS: Among 437,915 asthma patients receiving ICS-containing inhaler, 91,122 participants were included. Treatment groups were categorized as (1) ICS-containing inhalers (ICS with or without long-acting β-2 agonist (LABA)), and (2) ICS-containing inhalers used in combination with both oral montelukast and levocetirizine, and (3) severe exacerbation of asthma (visit of emergency room or hospitalization). After 1 : 1 propensity score matching of treatment groups, survival analysis utilizing Cox regression was conducted for estimating the effect of treatment on asthma exacerbation. RESULTS: We found that the inhaler plus montelukast and levocetirizine group exhibited a lower crude incidence rate and was associated with a lower risk of all-cause death and moderate to severe exacerbation. Specifically, the adjusted hazard ratios (HRs) were 0.71 (p = 0.006) for all-cause death, 0.57 (p < 0.001) for moderate exacerbation. For severe exacerbations, the adjusted HRs were 0.59 for emergency room visits and 0.66 for hospitalizations (p = 0.018 and 0.011, respectively), compared to the ICS-only group, demonstrating a statistically significant reduction. CONCLUSION: Treatment with ICS-containing inhaler plus oral montelukast and levocetirizine was significantly associated with a lower risk of exacerbations in asthma patients. Alongside the growing burden of healthcare utilization and costs in South Korea, consideration of the treatment of ICS with montelukast and levocetirizine may serve as an effective treatment option for patients with severe, uncontrolled asthma, potentially improving disease management and reducing healthcare costs.