Trial demonstrates improved symptom control in seasonal asthma, suggesting budesonide-formoterol offers better long-term efficacy and comparable safety profiles.
Objective: To compare the long-term efficacy and safety of budesonide-formoterol and montelukast in patients with seasonal asthma. Methods: A total of 270 outpatient asthma patients with seasonal exacerbation characteristics were selected from our hospital from March 2022 to September 2025 and randomly divided into three groups (A, B, and C), with 90 patients in each group. All patients received asthma health education. Patients in Group A inhaled budesonide-formoterol inhalation powder, patients in Group B took oral montelukast sodium tablets, and patients in Group C did not use any asthma control medications but only used salbutamol aerosol for symptomatic treatment during acute exacerbations. All patients were followed up for more than 2 years, and ACT scores, lung function indicators, and safety were compared. Results: (1) The ACT scores of Groups A and B were higher than those before treatment at 3, 6, 12, and 30 months of treatment (P<0.05), and continued to increase with the prolongation of treatment time, while there was no significant change in Group C (P>0.05). When comparing between groups, the ACT scores of Groups A and B were higher than those of Group C at 3, 6, 12, and 30 months of treatment (P<0.05), and Group A was significantly higher than Group B at 6, 12, and 30 months (P<0.05). (2) The FEV1 and FEV1/FVC of Groups A and B were higher than those before treatment at 3, 6, 12, and 30 months of treatment (P<0.05), while there was no significant change in Group C (P>0.05). When comparing between groups, the FEV1/FVC of Groups A and B were higher than those of Group C at 3, 6, 12, and 30 months of treatment (P<0.05), and Group A was significantly higher than Group B at 6, 12, and 30 months (P<0.05). (3) During the treatment period, there was no significant difference in the incidence of adverse reactions between Group A and Group B (P > 0.05). During the follow-up period, Group C experienced a total of 15 cases of asthma exacerbation complicated by other conditions, including 14 cases of pulmonary infection and 1 case of respiratory failure. All patients improved after symptomatic treatment, and no deaths occurred due to complications. Conclusion: Implementing preventive treatment for patients with seasonal asthma is of utmost importance. Both budesonide-formoterol and montelukast therapies can effectively alleviate patients' symptoms and exhibit comparable safety profiles. However, budesonide-formoterol demonstrates superior performance in long-term symptom control and lung function improvement. Clinical decision-making should comprehensively consider the specific conditions and treatment responses of patients to develop suitable individualized treatment plans.
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Han et al. (2025) studied this question.