• DOI:10.1056/NEJM200003163421102
• Corpus ID: 34434809

A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis.

@article{Stevens2000ART,
  title={A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis.},
  author={David A. Stevens and Howard J. Schwartz and J. Y. Lee and Bruce L. Moskovitz and Dennis Jerome and Antonino Catanzaro and David M. Bamberger and A J Weinmann and Carmelita U. Tuazon and Marc A. Judson and Thomas A E Platts-Mills and Arthur C. Degraff},
  journal={The New England journal of medicine},
  year={2000},
  volume={342 11},
  pages={
          756-62
        }
}

• D. Stevens, H. Schwartz, +9 authors A. Degraff
• Published 16 March 2000
• Medicine, Biology
• The New England journal of medicine

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.