• J. Allergy Clin. Immunol. · Jun 1999

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma.

    • W Busse, H Nelson, J Wolfe, C Kalberg, S W Yancey, and K A Rickard.
    • University of Wisconsin-Madison Medical School, Madison, WI, USA.
    • J. Allergy Clin. Immunol. 1999 Jun 1; 103 (6): 1075-80.

    BackgroundSalmeterol, a long-acting beta2 -agonist, and zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients.ObjectiveWe sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral zafirlukast in the treatment of persistent asthma.MethodsThis was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurrent inhaled corticosteroid regimen, were treated for 4 weeks with either inhaled salmeterol xinafoate 42 microgram twice daily administered by means of a metered-dose inhaler or oral zafirlukast 20 mg twice daily. The primary efficacy measure was morning peak expiratory flow (PEF); secondary efficacy measures included evening PEF, asthma symptom scores, supplemental albuterol use, nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV1.ResultsBoth inhaled salmeterol and oral zafirlukast resulted in within-group improvements from baseline in measures of pulmonary function, asthma symptoms, and supplemental albuterol use. Salmeterol treatment resulted in significantly greater improvements from baseline compared with zafirlukast for most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P ConclusionIn patients with persistent asthma, most of whom were concurrently using inhaled corticosteroids, treatment with inhaled salmeterol provided significantly greater improvement than oral zafirlukast in overall asthma control over the 4-week treatment period.

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