Chest
Clinical InvestigationsASTHMAZafirlukast Treatment for Acute Asthma: Evaluation in a Randomized, Double-Blind, Multicenter Trial
Section snippets
Materials and Methods
This trial was conducted in 20 US hospital-affiliated EDs. Patients aged 12 to 65 years who presented to the ED with acute asthma were screened by study investigators for trial eligibility. Eligible patients were those with a history of asthma and a FEV1 of < 70% predicted both at ED entry and 25 min after receiving a single aerosol treatment with 2.5 mg of albuterol. Patients with the following conditions were excluded from the study: history of smoking of > 10 pack-years; positive pregnancy
Patients
During the ED period, 641 patients were randomized to treatment as follows: Z160, 162 patients; Z20, 158 patients; and placebo, 321 patients (Fig 2). Demographic and disease characteristics at ED entry are presented in Table 1. The mean age was 32 years, and the mean FEV1 was 37.8% predicted. At the end of the ED period, 551 of 641 patients (86%) were discharged from the ED, and 546 patients entered the outpatient period. Of those, 276 were treated with Z20 bid and 270 were treated with placebo
Discussion
Previous studies10,11 have suggested that cysteinyl leukotrienes have a role in the pathophysiology of acute asthma. This multicenter trial showed that adding a leukotriene receptor antagonist to standardized ED therapy and routine discharge medication decreases the need for extended care in the ED and improves the 28-day outpatient relapse rate. Improvement in asthma symptoms and airway function occurred with the first dose in the ED, and many secondary outcomes improved throughout the trial.
Steering Committee
Robert Silverman, MD (Chair); Richard Nowak, MD; Emil Skobeloff, MD; Phillip Korenblat, MD; and Steven Simonson, MD.
Investigators
Leonard Altman, MD, Harbor View Medical Center, Seattle, WA; Paula J. Anderson, MD, University of Arkansas for Medical Sciences, Little Rock, AR; Raymond E. Brady, MD, Vancouver, WA; Ronald A. Charles, MD, Parkland Hospital, UT Southwestern Medical Center, Dallas, TX; William Calhoun, MD, Presbyterian University Hospital, University of Pittsburgh, Pittsburgh, PA; Charles Emerman,
ACKNOWLEDGMENT
The authors thank Jean Fennimore, BS, RN, Mike Koeferl, PhD, and Scott Tutak, BS, for trial initiation and management support, Susan Beatty, MD, for medical consultation, Marshall Joffe MD, PhD, for statistical review and propensity analysis, Suzanne Bristow-Marcalus, BSPharm, ELS, and Jeanne McFadden, ELS, for editorial and graphic assistance, and Kathy Walsh, eResearch Technology, Inc. (formerly Premier Research Worldwide, Philadelphia, PA), for assistance with the spirometry.
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Cited by (0)
This trial was supported by AstraZeneca (Wilmington, DE).
Drs. Silverman and Korenblat have served as consultants for AstraZeneca, Drs. Korenblat and Nowak are on the AstraZeneca speakers committee, and Drs. Simonson, Bonucelli, and Chen, and Mr. Miller are employees of AstraZeneca.
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Currently with Consortium Clinical Research, Upland, PA.
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A list of participating investigators and centers is located in the Appendix.