Abstract:

Objective To investigate the clinical symptom scoring and improvement of small airway function in children with moderate to severe allergic asthma and allergic rhinitis treated with omalizumab. Methods This prospective study enrolled 120 children with moderate-to-severe allergic asthma and comorbid allergic rhinitis who attended the Department of Pediatrics at Wuhan First Hospital between May 2023 and June 2025. All patients received standard baseline therapy. The control group was treated with budesonide/formoterol， while the study group received additional omalizumab on top of the control regimen. We compared inflammatory factors， cytokine levels， small airway function， and lung function before and after treatment， assessed symptom improvement at baseline， 6 months， and 12 months post-treatment， and evaluated clinical outcomes and adverse events during the 12-month treatment period. Results After 12 months of treatment， the study group showed a significantly higher C-ACT score and a lower TNSS score than the control group （P < 0.05）. Repeated-measures ANOVA revealed significant time， group， and interaction effects for both scores （P < 0.05）. Regarding lung function， the study group had higher FEV1%pred and PEF%pred values， as well as lower nasal nitric oxide （nNO） and nasal resistance （P < 0.05）. Small airway function parameters—FEF50%， FEF75%， and MMEF—were also superior in the study group （P<0.05）. Inflammatory and immune markers differed significantly： the study group exhibited lower levels of IL‑4， IL‑6， IL‑17A， IgE， eosinophils （EOS）， and fractional exhaled nitric oxide （FeNO）， but higher IFN‑γ levels （P < 0.05）. Finally， the study group scored higher across all domains of the Pediatric Asthma Quality of Life Questionnaire （PAQLQ）—including symptoms， activity limitation， and emotional function—as well as the total PAQLQ score （P < 0.05）. In the study group， serum total IgE levels were higher， while EOS counts and FeNO levels were lower than those in the control group （P < 0.05）. The study group also demonstrated superior scores across all PAQLQ domains—symptoms， activity limitation， and emotional function—as well as in the total score （P < 0.05）. Over the 12-month treatment period， the rates of asthma exacerbation and hospitalization were significantly lower in the study group than in the control group （P < 0.05）， whereas no significant difference was observed in the overall incidence of adverse events between the two groups （P > 0.05）. Conclusions In addition to budesonide/formoterol treatment， combination with omalizumab effectively controls clinical symptoms in children with moderate‑to‑severe allergic asthma and comorbid allergic rhinitis， improves airway function and small airway function， and by modulating inflammatory cytokine levels， contributes to the restoration of the T helper 1/T helper 2 （Th1/Th2） immune balance， suppresses allergic inflammatory responses， and enhances quality of life.

Key words: omalizumab, children, allergic asthma, rhinallergosis, small airway function, symptom rating