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Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients. In a separate study, treatment with montelukast significantly decreased eosinophils in the airways as measured in sputum. In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.

In studies in adults, montelukast, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1 Improvement in patient-reported daytime and night-time asthma symptoms scores was significantly better than placebo.

However, compared with beclomethasone, a high percentage of patients treated with montelukast achieved similar clinical responses e.

In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function FEV1 8. In a month study comparing the efficacy of montelukast to inhaled fluticasone on asthma control in paediatric patients 6 to 14 years of age with mild persistent asthma, montelukast was non-inferior to fluticasone in increasing the percentage of asthma rescue-free days RFDs , the primary endpoint.

Averaged over the month treatment period, the percentage of asthma RFDs increased from The between group difference in LS mean increase in the percentage of asthma RFDs was statistically significant Both montelukast and fluticasone also improved asthma control on secondary variables assessed over the 12 month treatment period: The between group difference in LS means for the percentage of days with beta-agonist use was significant: The between group difference in LS means was significant: Sixty percent of patients were not on any other controller therapy.

Montelukast improved daytime symptoms including coughing, wheezing, trouble breathing and activity limitation and night-time symptoms compared with placebo. Montelukast also decreased "as-needed" beta-agonist use and corticosteroid rescue for worsening asthma compared with placebo. Patients receiving montelukast had more days without asthma than those receiving placebo. A treatment effect was achieved after the first dose.

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