Immunocompromised host · Antifungal therapy in ABPA
A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis
| Design | Randomised, double-blind, placebo-controlled trial with an open-label extension |
|---|---|
| Treatment | Itraconazole 200 mg twice daily for 16 weeks |
| Control | Placebo |
| Population | 55 patients with corticosteroid-dependent allergic bronchopulmonary aspergillosis |
| Follow-up | 16 weeks double-blind, then open-label extension |
| Primary endpoint | Response — 50% reduction in corticosteroid dose, 25% fall in IgE, and improvement in exercise tolerance, lung function or radiology |
| Result | Response occurred in 13 of 28 (46%) on itraconazole versus 5 of 27 (19%) on placebo (p=0.04). Adverse event rates were similar. In the open-label phase 12 of 33 non-responders (36%) subsequently responded, and no double-blind responder relapsed. |
| Secondary endpoints | Corticosteroid dose, serum IgE, exercise tolerance, adverse events |
For patients with corticosteroid-dependent allergic bronchopulmonary aspergillosis, the addition of itraconazole can lead to improvement in the condition without added toxicity.
The trial authors, in the published abstract
Still the basis for antifungal therapy in ABPA, in a disease with very little randomised evidence. Fifty-five patients, a composite response endpoint, and a steroid-dependent population — so it speaks to the patient who cannot come off prednisolone rather than to ABPA generally. Drug interactions and hepatotoxicity, not efficacy, are what limit itraconazole in practice.
Stevens DA, Schwartz HJ, Lee JY, et al. A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis. N Engl J Med 2000 Mar 16;342(11):756-62.