Context: For asthmatic patients who remain symptomatic on inhaled corticosteroids, augmenting the therapy with additional long-term control medication is advocated. Long-acting beta2-adrenergic agonists and leukotriene modifiers are 2 therapeutic alternatives in the long-term controller class.
Objective: To compare the addition of a long-acting beta2-adrenergic agonist to the addition of an oral leukotriene modifier for asthma therapy in patients who remain symptomatic on inhaled corticosteroids.
Design: Double-blind, double-dummy, parallel-group, multicenter clinical studies.
Setting: 54 outpatient clinical centers.
Patients: 429 male and female patients with asthma 12 years of age and older who were symptomatic while taking inhaled corticosteroids.
Interventions: Salmeterol xinafoate 42 mcg via metered dose inhaler twice daily or oral zafirlukast 20 mg twice daily.
Main outcome measures: Pulmonary function, asthma symptoms, supplemental albuterol use, asthma quality of life scores, and adverse events.
Results: Inhaled salmeterol provided significantly greater improvement in pulmonary function as well as significantly greater relief of both daytime and nighttime asthma symptoms compared with oral zafirlukast in patients concurrently treated with inhaled corticosteroids. The use of supplemental albuterol was reduced to a greater extent with salmeterol compared with zafirlukast. Patients treated with salmeterol showed significantly greater improvement in Asthma Quality of Life Questionnaire (AQLQ) scores and were satisfied with how fast, how long, and how well the medication worked compared with patients in the zafirlukast group. Both treatments were well tolerated and demonstrated similar safety profiles.
Conclusions: In patients with moderate to severe persistent asthma not sufficiently controlled with inhaled corticosteroids alone, the combination of inhaled salmeterol and inhaled corticosteroids is superior to the combination of oral zafirlukast and inhaled corticosteroids as stepwise therapy.