Abstract | BACKGROUND: 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:
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Authors | D A Stevens, H J Schwartz, J Y Lee, B L Moskovitz, D C Jerome, A Catanzaro, D M Bamberger, A J Weinmann, C U Tuazon, M A Judson, T A Platts-Mills, A C DeGraff Jr |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 342
Issue 11
Pg. 756-62
(Mar 16 2000)
ISSN: 0028-4793 [Print] United States |
PMID | 10717010
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Adrenal Cortex Hormones
- Antifungal Agents
- Itraconazole
- Immunoglobulin E
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Topics |
- Adrenal Cortex Hormones
(therapeutic use)
- Antifungal Agents
(adverse effects, therapeutic use)
- Aspergillosis, Allergic Bronchopulmonary
(drug therapy, immunology)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Immunoglobulin E
(blood)
- Itraconazole
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Treatment Outcome
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