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Montelukast + roflumilast is an oral combination therapy consisting of two small molecule drugs with distinct anti-inflammatory mechanisms, investigated primarily for the treatment of moderate-to-severe asthma not adequately controlled by inhaled corticosteroids and long-acting beta-agonists. Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotriene type 1 (CysLT1) receptors, thereby reducing airway inflammation and bronchoconstriction. Roflumilast is a selective phosphodiesterase 4 (PDE4) inhibitor that increases intracellular cyclic AMP in lung cells, leading to reduced inflammatory cell activity. Clinical studies have shown that this combination improves lung function, asthma control scores, and reduces urinary leukotriene E4 levels compared to montelukast alone in patients with moderate-to-severe asthma[1][2][5][6]. The safety profile was consistent with known effects of the individual agents.
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