Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma

Background: Salmeterol, a long-acting beta(2)-agonist, and zafirlukast, a l eukotriene receptor antagonist, are both indicated for the treatment of ast hma in adolescent and adult patients. Objective: We sought to compare the effect of 4 weeks of treatment with inh aled salmeterol xinafoate versus oral zafirlukast in the treatment of persi stent asthma. Methods: This was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurren t inhaled corticosteroid regimen, were treated for 4 weeks with either inha led salmeterol xinafoate 42 mu g twice daily administered by means of a met ered dose inhaler or oral zafirlukast 20 mg twice daily. The primary effica cy measure was morning peak expiratory flow (PEF); secondary efficacy measu res included evening PEF, asthma symptom scores, supplemental albuterol use , nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV1. Results: Both inhaled salmeterol and oral zafirlukast resulted in within-gr oup improvements from baseline in measures of pulmonary function, asthma sy mptoms, and supplemental albuterol use. Salmeterol treatment resulted in si gnificantly greater improvements from baseline compared with zafirlukast fo r most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P less than or equal to .001), percentage of symptom-free days (22.4% vs 8.8% ; P less than or equal to .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P less than or equal to .001), There were no differences in safety profiles as assessed by adverse event m onitoring. Conclusion: In patients with persistent asthma, most of whom were concurren tly using inhaled corticosteroids, treatment with inhaled salmeterol provid ed significantly greater improvement than oral zafirlukast in overall asthm a control over the 4-week treatment period.