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Войти в исследования International archives of allergy and immunology · 2026
Montelukast combined with ICS/LABA improves clinical outcomes in moderate-to-severe persistent asthma by modulating T lymphocyte subset-related cytokine profiles.
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Cai Wanlong, Cao Yinghua, Wang Li, Zhou Shengli, Ge Qixing, Zhao Mingming, Yan Haipeng
Аннотация
BACKGROUND: Glucocorticoids and montelukast, an anti-leukotriene agent, target different inflammatory pathways. This study aims to investigate the immunological synergy of their combination.
METHODS: A prospective, randomized, controlled, open-label study was conducted. Two hundred and third-four patients were randomly assigned to two groups for a 12-week treatment period. Control group [ICS+long-acting beta₂-agonist (LABA)]; n = 118): Budesonide 400 µg/day (200 µg twice daily) + formoterol 18 µg/day (9 µg twice daily). Combination group (n = 116): Same ICS+LABA regimen + Montelukast 10 mg orally once daily.
RESULTS: At Week 12, the ICS+LABA+Mon group demonstrated significantly greater improvements in pre-bronchodilator FEV₁ compared with the ICS+LABA group (mean change: +239.0 ± 70.5 mL vs. +141.2 ± 47.9 mL; between-group difference 97.8 mL; 95% CI: 82.4 to 113.2; P < 0.001). Asthma control improved more substantially with combination therapy, as shown by greater ACQ-6 score reductions, with the mean score in the combination group approaching the well-controlled threshold. Immunologically, combination therapy produced a significantly greater increase in IFN-γ and Treg cytokines IL-10 and TGF-β, alongside more pronounced suppression of T helper 2 (Th2) cytokines (IL-4, IL-5, and IL-13) and the Th17 cytokine IL-17.
CONCLUSIONS: The addition of montelukast to ICS+LABA therapy significantly enhances pulmonary function, asthma control, and suppression of eosinophilic airway inflammation in moderate-to-severe persistent asthma via a favorable immunological shift characterized by enhanced Th1 and Treg responses and more potent suppression of Th2 and Th17 pathways.
METHODS: A prospective, randomized, controlled, open-label study was conducted. Two hundred and third-four patients were randomly assigned to two groups for a 12-week treatment period. Control group [ICS+long-acting beta₂-agonist (LABA)]; n = 118): Budesonide 400 µg/day (200 µg twice daily) + formoterol 18 µg/day (9 µg twice daily). Combination group (n = 116): Same ICS+LABA regimen + Montelukast 10 mg orally once daily.
RESULTS: At Week 12, the ICS+LABA+Mon group demonstrated significantly greater improvements in pre-bronchodilator FEV₁ compared with the ICS+LABA group (mean change: +239.0 ± 70.5 mL vs. +141.2 ± 47.9 mL; between-group difference 97.8 mL; 95% CI: 82.4 to 113.2; P < 0.001). Asthma control improved more substantially with combination therapy, as shown by greater ACQ-6 score reductions, with the mean score in the combination group approaching the well-controlled threshold. Immunologically, combination therapy produced a significantly greater increase in IFN-γ and Treg cytokines IL-10 and TGF-β, alongside more pronounced suppression of T helper 2 (Th2) cytokines (IL-4, IL-5, and IL-13) and the Th17 cytokine IL-17.
CONCLUSIONS: The addition of montelukast to ICS+LABA therapy significantly enhances pulmonary function, asthma control, and suppression of eosinophilic airway inflammation in moderate-to-severe persistent asthma via a favorable immunological shift characterized by enhanced Th1 and Treg responses and more potent suppression of Th2 and Th17 pathways.