Oral Montelukast Sodium versus Inhaled Fluticasone Propionate in Adults with Mild Persistent Asthma

Objective: Asthma consensus guidelines recommend the use of a controller agent to control asthma symptoms and reduce inflammation in patients with mild asthma. The objective of this study was to compare montelukast to inhaled fluticasone on the percentage of asthma-free days in patients with mild persistent asthma during 48 weeks of active treatment. Methods: This was a randomized, multicenter study with a 3-week single-blind run-in period, followed by a 12-week double-blind active treatment period, and a 36-week open-label active treatment period. Patients (aged 15 to 80 years) with mild persistent asthma as established by the Global Initiative for Asthma (GINA) guidelines were randomized to receive oral montelukast 10 mg (n=325) or fluticasone 100 μg (n=320) twice daily by metered-dose inhaler. An analysis of covariance model was used to analyze the primary endpoint of asthma-free days. Montelukast 01Polos-vol5no3 1/26/70 6:27 PM Page 402