A comparative study to evaluate the efficacy and safety of montelukast monotherapy versus montelukast plus levocetrizine combination therapy in paediatric asthma patients with allergic rhinitis.

Allergic rhinitis (AR) is a common atopic disease affecting approximately 10–30% of adults and up to 40% of children globally, while in India about 20–30% of children are affected. Bronchial asthma is a chronic inflammatory airway disease affecting around 262 million people worldwide, with a prevalence of about 2–18%, and approximately 5–7% of children in India, particularly in urban and semi-urban areas. Allergic rhinitis and bronchial asthma frequently coexist and share common inflammatory pathways, a concept described as the “united airway disease,” where involvement of the upper airway often influences lower airway disease, leading to poorer asthma control and increased exacerbations.This study will be conducted in children aged 6 to 12 years suffering from bronchial asthma with allergic rhinitis, in which a total of 70 participants will be randomly divided into two groups. One group will receive montelukast monotherapy, while the other group will receive a combination of montelukast and levocetirizine. The efficacy of treatment will be assessed by comparing Asthma Control Test (ACT) scores, Total Nasal Symptom Score (TNSS), and spirometry parameters at baseline and at 8 weeks. Safety will be evaluated by monitoring and recording any adverse drug reactions during the study period, and the outcomes of both groups will be compared to determine the more effective and safer treatment option in children.