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
Background Although guidelines recommend daily therapy for patientswith mild persistent asthma, prescription patterns suggest thatmost such patients use these so-called controller therapiesintermittently. In patients with mild persistent asthma, weevaluated the efficacy of intermittent short-course corticosteroidtreatment guided by a symptom-based action plan alone or inaddition to daily treatment with either inhaled budesonide ororal 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 onesecond (FEV1) before and after bronchodilator treatment, thefrequency of exacerbations, the degree of asthma control, thenumber of symptom-free days, and the quality of life.
Results The three treatments produced similar increases in morningPEF (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 withintermittent therapy or daily zafirlukast therapy, daily budesonidetherapy produced greater improvements in pre-bronchodilatorFEV1 (P=0.005), bronchial reactivity (P<0.001), the percentageof eosinophils in sputum (P=0.007), exhaled nitric oxide levels(P=0.006), scores for asthma control (P<0.001), and the numberof symptom-free days (P=0.03), but not in post-bronchodilatorFEV1 (P=0.29) or in the quality of life (P=0.18). Daily zafirlukasttherapy did not differ significantly from intermittent treatmentin any outcome measured.
Conclusions It may be possible to treat mild persistent asthmawith short, intermittent courses of inhaled or oral corticosteroidstaken when symptoms worsen. Further studies are required todetermine whether this novel approach to treatment should berecommended.
Source Information
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.).
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.
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N Engl J Med 2005;
353:424-427, Jul 28, 2005.
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