Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma,☆☆,

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Abstract

Background: Salmeterol, a long-acting β2 -agonist, and zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients. Objective: We sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral zafirlukast in the treatment of persistent asthma. Methods: This 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 μg 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 . Results: Both 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 ≤ .001), percentage of symptom-free days (22.4% vs 8.8%; P ≤ .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P ≤ .001). There were no differences in safety profiles as assessed by adverse event monitoring. Conclusion: In 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. (J Allergy Clin Immunol 1999;103:1075-80.)

Section snippets

Study design and patients

This randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial compared the efficacy and safety of inhaled salmeterol xinafoate (Serevent; Glaxo Wellcome Inc, Research Triangle Park, NC) at a dose of 42 μg twice daily (2 puffs), administered by means of a metered-dose inhaler, with oral zafirlukast (Accolate; Zeneca Pharmaceuticals, Wilmington, Del) at a dose of 20 mg twice daily over a 4-week treatment period in adolescents and adults with persistent asthma. This study

Demographics

A total of 144 patients received inhaled salmeterol and 145 received oral zafirlukast in this trial. Demographic and baseline disease characteristics were similar in the 2 treatment groups (Table I)Approximately 80% of the patients in each treatment group were on a stable regimen of ICSs.

Pulmonary function

PEF. Baseline morning and evening PEF were comparable between the 2 groups (371.8 and 392.1 L/min, respectively, in the salmeterol group; 368.5 and 398.3 L/min, respectively, in the zafirlukast group).

DISCUSSION

This study is the first to compare a leukotriene receptor antagonist to a long-acting β-agonist. Previous studies have characterized the efficacy of zafirlukast in patients with mild-to-moderate persistent asthma who were not using concomitant inhaled steroids.2, 3, 4 The effects of zafirlukast in a patient population that is heterogeneous with regard to ICS use have not been studied. The current study included patients who were and patients who were not using ICSs. This was an appropriate

Acknowledgements

We thank Amanda Emmett for her assistance in performing the statistical analyses for this study and Larry East for his expert assistance in the preparation of this manuscript.

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Supported by Glaxo Wellcome Inc, Research Triangle Park, NC.

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Reprint requests: William Busse, MD, University of Wisconsin-Madison Medical School, Department of Medicine, 15/220 Clinical Science Center 600 Highland Avenue, Madison, WI 53792-2454.

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