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

would be considered at least as effective as fluticasone if the treatment differ-ence (average percentage of asthma-free days on fluticasone minus average percentage of asthma-free days on mon-telukast) was below 10 % (3 days/ month). Secondary endpoints were “as-needed ” b-agonist use, days with symp-toms, rescue-free days, asthma-specific quality of life, forced expiratory volume in 1 second (FEV1), morning peak expi-ratory flow, asthma attacks, nocturnal awakenings, patient global assessment of asthma, blood eosinophil count, and safety and tolerability. Results: Patients taking fluticasone had 6.44 % (95 % confidence interval [CI] 2.24, 10.64) more asthma-free days than did patients taking montelukast (<2 days/month/patient). The CI included the non-inferiority boundary of 10%. Both montelukast and fluticasone showed an improvement in asthma-related efficacy endpoints, except FEV1, which was improved only for patients taking fluticasone. Both montelukast and fluticasone were well tolerated.