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Original Article
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Volume 352:1519-1528 April 14, 2005 Number 15
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Daily versus As-Needed Corticosteroids for Mild Persistent Asthma
Homer A. Boushey, M.D., Christine A. Sorkness, Pharm.D., Tonya S. King, Ph.D., Sean D. Sullivan, Ph.D., John V. Fahy, M.D., Stephen C. Lazarus, M.D., Vernon M. Chinchilli, Ph.D., Timothy J. Craig, D.O., Emily A. Dimango, M.D., Aaron Deykin, M.D., Joanne K. Fagan, Ph.D., James E. Fish, M.D., Jean G. Ford, M.D., Monica Kraft, M.D., Robert F. Lemanske, Jr., M.D., Frank T. Leone, M.D., Richard J. Martin, M.D., Elizabeth A. Mauger, Ph.D., Gene R. Pesola, M.D., M.P.H., Stephen P. Peters, M.D., Ph.D., Nancy J. Rollings, M.Ed., Stanley J. Szefler, M.D., Michael E. Wechsler, M.D., Elliot Israel, M.D., for the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network

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ABSTRACT

Background Although guidelines recommend daily therapy for patients with mild persistent asthma, prescription patterns suggest that most such patients use these so-called controller therapies intermittently. In patients with mild persistent asthma, we evaluated the efficacy of intermittent short-course corticosteroid treatment guided by a symptom-based action plan alone or in addition to daily treatment with either inhaled budesonide or oral zafirlukast over a one-year period.

Methods In a double-blind trial, 225 adults underwent randomization. The primary outcome was morning peak expiratory flow (PEF). Other outcomes included the forced expiratory volume in one second (FEV1) before and after bronchodilator treatment, the frequency of exacerbations, the degree of asthma control, the number of symptom-free days, and the quality of life.

Results The three treatments produced similar increases in morning PEF (7.1 to 8.3 percent; approximately 32 liters per minute; P=0.90) and similar rates of asthma exacerbations (P=0.24), even though the intermittent-treatment group took budesonide, on average, for only 0.5 week of the year. As compared with intermittent therapy or daily zafirlukast therapy, daily budesonide therapy produced greater improvements in pre-bronchodilator FEV1 (P=0.005), bronchial reactivity (P<0.001), the percentage of eosinophils in sputum (P=0.007), exhaled nitric oxide levels (P=0.006), scores for asthma control (P<0.001), and the number of symptom-free days (P=0.03), but not in post-bronchodilator FEV1 (P=0.29) or in the quality of life (P=0.18). Daily zafirlukast therapy did not differ significantly from intermittent treatment in any outcome measured.

Conclusions It may be possible to treat mild persistent asthma with short, intermittent courses of inhaled or oral corticosteroids taken when symptoms worsen. Further studies are required to determine whether this novel approach to treatment should be recommended.


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From the University of California at San Francisco, San Francisco (H.A.B., J.V.F., S.C.L.); University of Wisconsin, Madison (C.A.S., R.F.L.); Pennsylvania State University College of Medicine, Hershey (T.S.K., V.M.C., T.J.C., E.A.M., N.J.R.); University of Washington, Seattle (S.D.S.); Harlem Lung Center and Columbia University, New York (E.A.D., J.K.F., J.G.F., G.R.P.); Brigham and Women's Hospital and Harvard Medical School, Boston (A.D., M.E.W., E.I.); Thomas Jefferson University, Philadelphia (J.E.F., F.T.L., S.P.P.); and the National Jewish Medical and Research Center, Denver (M.K., R.J.M., S.J.S.).

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Related Letters:

Treatment of Mild Asthma
Berti I., Longo G., Visintin S., Chowdhury B. A., Jenkins C. R., Marks G. B., Reddel H. K., Lee D. K.C., Raghupathy A., Brashier B., Salvi S., Boushey H. A., Israel E., Fabbri L. M.
Extract | Full Text | PDF  
N Engl J Med 2005; 353:424-427, Jul 28, 2005. Correspondence

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