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Zafirlukast Treatment for Acute Asthma^*

Evaluation in a Randomized, Double-Blind, Multicenter Trial

Robert A. Silverman, MD; Richard M. Nowak, MD; Phillip E. Korenblat, MD; Emil Skobeloff, MD; Yusong Chen, PhD; Catherine M. Bonuccelli, MD; Christopher J. Miller, MStat and Steven G. Simonson, MD, FCCP

^* From the Long Island Jewish Medical Center (Dr. Silverman), New Hyde Park, NY; the Henry Ford Health System (Dr. Nowak), Detroit, MI; Barnes-Jewish Hospital (Dr. Korenblat), St. Louis, MO; Crozer-Chester Medical Center (Dr. Skobeloff), Upland, PA; and AstraZeneca Pharmaceuticals LP (Drs. Chen, Bonuccelli, and Simonson, and Mr. Miller), Wilmington, DE.

Correspondence to: Robert A. Silverman, MD, Long Island Jewish Medical Center, 270–05 76th Ave, New Hyde Park, NY 11042; e-mail: aresilv{at}aol.com

Context: Acute asthma causes nearly 2 million hospital emergency department (ED) visits in the United States annually, and hospitalization after an ED visit and relapse after ED discharge are common.

Objective: To evaluate the adding of therapy with zafirlukast to standardized care for patients with acute asthma in the ED and a 28-day follow-up period.

Design and patients: A total of 641 patients presenting to the ED with acute asthma were randomized to receive either single-dose zafirlukast, 160 mg (Z160) [162 patients], zafirlukast, 20 mg (Z20) [158 patients]), or placebo (321 patients) as adjunct treatment to standard care in this double-blind, multicenter trial. Assessments, including spirometry and symptom scores, were obtained before each albuterol treatment and at 4 h. Patients who were discharged from the ED after 4 h continued outpatient therapy over a 28-day period and received either Z20 bid (276 patients) or placebo (270 patients) in addition to prednisone, albuterol, and their previous asthma medications. FEV₁ was measured at clinic visits on days 10 and 28. Patients recorded outpatient clinical data twice daily on a home diary card.

Main outcome measures: the effect of zafirlukast on relapse after ED discharge. Other assessments were the rate of extended care (ie, ED stay for > 4 h or hospitalization), FEV₁, and symptoms.

Results: At the end of the outpatient period, 65 of 276 patients (23.6%) treated with zafirlukast and 78 of 270 patients (28.9%) treated with placebo relapsed (p = 0.047; absolute reduction, 5.3%; relative reduction, 18.3%). At the end of the ED period, 16 of 162 patients (9.9%) treated with Z160, 26 of 158 patients (16.5%) treated with Z20, and 48 of 321 patients (15.0%) treated with placebo required extended care (p = 0.052; absolute reduction with Z160 compared to placebo, 5.1%; relative reduction, 34%). These findings were supported by a significant improvement in FEV₁ and dyspnea in the ED with the use of Z160 therapy, and by greater improvement in FEV₁ and symptoms during the outpatient period for patients treated with Z20.

Conclusions: When added to standardized care, therapy with Z20 bid reduced the risk of relapse compared with placebo over a 28-day treatment period. One dose of Z160 in the ED also reduced the rate of extended care.

Key Words: acute illness • asthma • leukotrienes • relapse • zafirlukast

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