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Journal of Allergy and Clinical Immunology

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Significant variability in response to inhaled corticosteroids for persistent asthma - 01/09/11

Doi : 10.1067/mai.2002.122635 
Stanley J. Szefler, MD, Richard J. Martin, MD, Tonya Sharp King, PhD, Homer A. Boushey, MD, Reuben M. Cherniack, MD, Vernon M. Chinchilli, PhD, Timothy J. Craig, DO, Myrna Dolovich, PEng, Jeffrey M. Drazen, MD, Joanne K. Fagan, PhD, John V. Fahy, MB, ChB, James E. Fish, MD, Jean G. Ford, MD, Elliot Israel, MD, James Kiley, PhD, Monica Kraft, MD, Stephen C. Lazarus, MD, Robert F. Lemanske, MD, Elizabeth Mauger, PhD, Stephen P. Peters, MD, PhD, Christine A. Sorkness, PharmD

for the Asthma Clinical Research Network of the National Heart Lung Blood Institute

Denver, Colo, Boston, Mass, New York, NY, Hershey, Pa, Madison, Wis, Philadelphia, Pa, San Francisco, Calif, Hamilton, Ontario, Canada, and Bethesda, Md 
From the National Jewish Medical and Research Center, Denver (R.M.C., M.K., R.J.M., S.J.S.); Brigham and Women's Hospital and Harvard Medical School, Boston (J.D., E.I.); Harlem Hospital Center and Columbia University, New York City (J.G.F., J.F.); Pennsylvania State University and Milton S. Hershey Medical Center, Hershey (V.M.C., T.J.C., T.S.K., E.M.); the University of Wisconsin, Madison (R.F.L., C.A.S.); Thomas Jefferson University, Philadelphia (J.E.F., S.P.P.); the University of California at San Francisco (S.C.L., H.A.B., J.V.F.); McMaster University, Hamilton (M.D.); and the National Heart, Lung and Blood Institute (J.K) 

Abstract

Background: A clinical model is needed to compare inhaled corticosteroids (ICSs) with respect to efficacy. Objective: The purpose of this investigation was to compare the relative beneficial and systemic effects in a dose-response relationship for 2 ICSs. Methods: A 24-week, parallel, open-label, multicenter trial examined the benefit-risk ratio of 2 ICSs in persistent asthma. Benefit was assessed by improvements in FEV1 and PC20; risk was assessed by overnight plasma cortisol suppression. Thirty subjects were randomized to either beclomethasone dipropionate (BDP) 168, 672, and 1344 μg/day (n = 15) or fluticasone propionate (FP) 88, 352, and 704 μg/day (n = 15), both administered by means of a metered dose inhaler (MDI) with chlorofluorocarbon propellant via a spacer, in 3 consecutive 6-week intervals; this was followed by 3 weeks of FP dry powder inhaler (DPI) 2000 μg/day. Results: Maximum FEV1 response occurred with the low dose for FP-MDI and the medium dose for BDP-MDI and was not further increased by treatment with FP-DPI. Near-maximum methacholine PC20 improvement occurred with the low dose for FP-MDI and the medium dose for BDP-MDI. Both BDP-MDI and FP-MDI caused dose-dependent cortisol suppression. Responsiveness to ICS treatment was found to vary markedly among subjects. Good (>15%) FEV1 response, in contrast to poor (<5%) response, was found to be associated with high exhaled nitric oxide (median, 17.6 vs 11.1 ppb), high bronchodilator reversibility (25.2% vs 8.8%), and a low FEV1/forced vital capacity ratio (0.63 vs 0.73) before treatment. Excellent (>3 doubling dilutions) improvement in PC20, in contrast to poor (<1 doubling dilution) improvement, was found to be associated with high sputum eosinophil levels (3.4% vs 0.1%) and older age at onset of asthma (age, 20-29 years vs <10 years). Conclusions: Near-maximal FEV1 and PC20 effects occurred with low-medium dose for both ICSs in the subjects studied. High-dose ICS therapy did not significantly increase the efficacy measures that were evaluated, but it did increase the systemic effect measure, overnight cortisol secretion. Significant intersubject variability in response occurred with both ICSs. It is possible that higher doses of ICSs are necessary to manage more severe patients or to achieve goals of therapy not evaluated in this study, such as prevention of asthma exacerbations. (J Allergy Clin Immunol 2002;109:410-8.)

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Keywords : Asthma, beclomethasone dipropionate, exhaled nitric oxide, fluticasone propionate, inhaled corticosteroid, methacholine response, pulmonary response

Abbreviations : ACRN:, BDP:, DPI:, eNO:, ED:, FPD:, FP:, ICS:, MDI:


Plan


 Supported by grants U10 HL-51810, U10 HL-51823, U10 HL-51831, U10 HL-51834, U10 HL-51843, U10 HL-51845, and U10 HL-56443 from the National Heart, Lung, and Blood Institute.
 This study was carried out in part in the General Clinical Research Centers at the University of Wisconsin, Brigham and Women's Hospital, Columbia University, and the University of California San Francisco with funds provided by the National Center for Research Resources (5 M01 RR-00079, M01-RR-00645, M01-RR02635, and M01-RR-03186, US Public Health Service).
 Reprint requests: Stanley J. Szefler, MD, National Jewish Medical and Research Center, Department of Pediatrics, Room B104a, 1400 Jackson Street, Denver, CO 80206.


© 2002  Mosby, Inc. Tous droits réservés.
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Vol 109 - N° 3

P. 410-418 - mars 2002 Retour au numéro
Article précédent Article précédent
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