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Real-World Clinical Outcomes and Safety of Montelukast in Pediatric Mild-to-Moderate Asthma: A Retrospective Observational Study

Year: 2026

Type: article

Abstract: Background: Montelukast is commonly prescribed as an adjunctive controller therapy in pediatric asthma, particularly among children with mild-to-moderate disease, allergic comorbidities, or challenges related to inhaled therapy adherence. However, real-world evidence regarding asthma-related outcomes, adherence patterns, and safety in routine pediatric practice remains limited. Objective: To evaluate asthma-related clinical outcomes, treatment adherence, and safety observations associated with montelukast therapy among pediatric patients with mild-to-moderate asthma in routine clinical practice. Methods: This retrospective observational pre-post study included pediatric patients aged 2-14 years with physician-documented mild-to-moderate asthma who received montelukast therapy for at least six consecutive months at Prince Sultan Military Medical City, Riyadh, Saudi Arabia, between January 2023 and May 2024. Data extracted from electronic medical records included asthma exacerbations, systemic corticosteroid use, rescue medication use, treatment adherence, and documented adverse events before and after montelukast initiation. Paired and comparative statistical analyses were performed to evaluate changes in asthma-related outcomes and factors associated with clinical improvement. Results: A total of 149 pediatric patients were included, with a median age of 8 years; 69.8% were male. Montelukast initiation was significantly associated with observed reductions in asthma exacerbations from one episode (range:0-12) before treatment to zero episodes (range: 0-6) after treatment (p=001), systemic corticosteroid use from one corticosteroid course (range -6) before treatment to zero courses (range: 0-6) following montelukast therapy (p = 0.006), and reduced rescue medication requirements. Physician-documented clinical improvement was observed in 61.1% of patients. Treatment adherence was strongly associated with improved clinical outcomes. Documented adverse events were uncommon, with behavioral symptoms reported in 2% of patients and no serious treatment-related adverse events identified during follow-up. Conclusion: Montelukast therapy was associated with favorable asthma-related outcomes and was generally well tolerated. Treatment adherence appeared to play an important role in clinical improvement. However, given the retrospective observational design and absence of a control group, prospective controlled studies are needed to further evaluate the long-term effectiveness and safety of montelukast in pediatric asthma management.

Source: Journal of Asthma and Allergy

DOI: 10.2147/jaa.s630759