Chest
Original Research: AsthmaFEV1Performance Among Patients With Acute Asthma: Results From a Multicenter Clinical Trial
Section snippets
Materials and Methods
Inclusion and exclusion criteria for the trial have been described.10Briefly, patients were 12 to 65 years old and presented with an acute episode of asthma, with FEV1<70% of predicted at ED entry and after a single aerosol treatment with albuterol. Spirometry was performed on ED arrival (baseline, time 0) and after 30, 60, 120, and 240 min. Albuterol treatments were administered after each spirometry test. For patients not hospitalized, follow-up spirometry was scheduled at day 10 and day 28
Results
A total of 641 patients from 20 sites were enrolled in the clinical trial. Performance data from 620 of 641 patients (97%) with 3,782 time points and 13,615 spirometry maneuvers were available for analysis. The missing data included all performance data from 1 site (four patients), leaving 19 sites in the analysis. Spirometry was performed by 107 different investigators, two thirds of whom had no previous experience performing spirometry. The average patient age was 33 years, and almost half
Discussion
In contrast to most outpatient settings, the patients studied were acutely ill and severely obstructed and not expecting to perform spirometry during their ED visit. This study shows that with a strong emphasis on several quality measures, spirometry for the purpose of obtaining an FEV1can be performed in acutely ill ED asthmatics. Most patients (almost three quarters) were able to perform study-specific acceptable and reproducible tests on ED arrival. As FEV1improved with treatments, and
Appendix
The following were the principal investigators at the participating sites: 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, MD, The Cleveland Clinic Foundation,
Acknowledgments
The authors thank AstraZeneca, Ltd, for providing the clinical trial database. The authors also thank Jean Fennimore, BS, RN, Mike Koeferl, PhD, and Scott Tutak, BS for trial management support; and Kathy Walsh, eResearch Technology, Inc., for assistance with spirometry data management.
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Cited by (0)
None of the investigators have any financial interest in the company that manufactures the spirometer used in the study. Dr. Silverman has consulted for AstraZeneca, and Dr. Simonson is an employee of AstraZeneca. Ms. Flaster and Dr. Enright have no conflicts of interest to report.
Data analysis was supported in part by an unrestricted research grant from AstraZeneca Ltd.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestjournal.org/misc/reprints.shtml).