{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:42:32Z","timestamp":1792600952731,"version":"4.5.0"},"reference-count":32,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:00:00Z","timestamp":1792022400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:00:00Z","timestamp":1792022400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int Arch Allergy Immunol"],"abstract":"<jats:p>Introduction: 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. Overall, 234 patients were randomly assigned to two groups for a 12-week treatment period: control group (ICS + long-acting beta&lt;sub&gt;2&lt;\/sub&gt; agonist [LABA]; n = 118): budesonide 400 \u03bcg\/day (200 \u03bcg twice daily) + formoterol 18 \u03bcg\/day (9 \u03bcg 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 FEV&lt;sub&gt;1&lt;\/sub&gt; compared with the ICS + LABA group (mean change: +239.0 \u00b1 70.5 mL vs. +141.2 \u00b1 47.9 mL; between-group difference 97.8 mL; 95% CI: 82.4\u2013113.2; p &lt; 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-\u03b3 and Treg cytokines IL-10 and TGF-\u03b2, alongside more pronounced suppression of T helper 2 (Th2) cytokines (IL-4, IL-5, and IL-13) and the Th17 cytokine IL-17. Conclusion: 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.<\/jats:p>","DOI":"10.1159\/iaa\/adfag023","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T11:19:46Z","timestamp":1788520786000},"page":"1-1","source":"Crossref","is-referenced-by-count":0,"title":["Montelukast Combined with ICS\/LABA Improves Clinical Outcomes in Moderate-to-Severe Persistent Asthma by Modulating T-Lymphocyte Subset-Related Cytokine 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