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Background Allergic bronchopulmonary aspergillosis is a hypersensitivity disorder that can progress from an acute phase to chronic disease. The main treatment is systemic corticosteroids, but data from uncontrolled studies suggest that itraconazole, an orally administered antifungal agent, may be an effective adjunctive therapy.
Methods We conducted a randomized, double-blind trial of treatment with either 200 mg of itraconazole twice daily or placebo for 16 weeks in patients who met immunologic and pulmonary-function criteria for corticosteroid-dependent allergic bronchopulmonary aspergillosis. A response was defined as a reduction of at least 50 percent in the corticosteroid dose, a decrease of at least 25 percent in the serum IgE concentration, and one of the following: an improvement of at least 25 percent in exercise tolerance or pulmonary-function tests or resolution or absence of pulmonary infiltrates. In a second, open-label part of the trial, all the patients received 200 mg of itraconazole per day for 16 weeks.
Results There were responses in 13 of 28 patients in the itraconazole group (46 percent), as compared with 5 of 27 patients in the placebo group (19 percent, P=0.04). The rate of adverse events was similar in the two groups. In the subsequent open-label phase, 12 of the 33 patients who had not had a response during the double-blind phase (36 percent) had responses, and none of the patients who had a response in the double-blind phase of the trial had a relapse.
Conclusions For patients with corticosteroid-dependent allergic bronchopulmonary aspergillosis, the addition of itraconazole can lead to improvement in the condition without added toxicity.
Source Information
From the Department of Medicine, Santa Clara Valley Medical Center, San Jose, Calif. (D.A.S.); the Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University Medical School, Stanford, Calif. (D.A.S.); the National Institute of Allergy and Infectious Diseases Mycoses Study Group, National Institutes of Health, Bethesda, Md. (D.A.S., A.C.); the Department of Medicine, Case Western Reserve University and University Hospitals, Cleveland (H.J.S.); the University of Alabama, Birmingham (J.Y.L.); Janssen Pharmaceutica, Titusville, N.J. (B.L.M.); Veterans Affairs Medical Center, Long Beach, Calif. (D.C.J.); the Department of Medicine, University of Missouri–Kansas City School of Medicine, Kansas City (D.M.B.); the Division of Infectious Diseases, Wayne State University, Detroit (A.J.W.); George Washington University Medical Center, Washington, D.C. (C.U.T.); the Pulmonary and Critical Care Division, Medical University of South Carolina, Charleston (M.A.J.); the Department of Medicine, University of Virginia, Charlottesville (T.A.E.P.-M.); and the Department of Medicine, University of Connecticut, Hartford (A.C.D.). Other authors were Jay Grossman, M.D., Vivra Research, Tucson, Ariz.; Raymond G. Slavin, M.D., St. Louis University School of Medicine, St. Louis; and Peter Reuman, National Institute of Allergy and Infectious Diseases Mycoses Study Group, National Institutes of Health, Bethesda, Md.Presented in part at the Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 28–October 1, 1997, and the American Academy of Allergy, Asthma and Immunology, Orlando, Fla., February 26–March 3, 1999.
Address reprint requests to Dr. Stevens at the Department of Medicine, Santa Clara Valley Medical Center, 751 S. Bascom Ave., San Jose, CA 95128-2699, or at stevens{at}leland.stanford.edu.
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