Trial of ketoconazole in non-invasive pulmonary aspergillosis.

A one year study of the efficacy of the antifungal agent ketoconazole in non-invasive pulmonary aspergillosis was carried out. Ten patients, seven with allergic bronchopulmonary aspergillosis and three with mycetoma, were studied. They were randomly allocated to receive 400 mg daily or placebo orally in a double blind fashion. In the treated group (n = 6), concentrations of serum IgG specific for Aspergillus fumigatus fell significantly during treatment (mean reduction 42% (SEM 2.2%) compared with determinations preceding the study). This effect was evident by three months and continued for the 12 months of treatment. Patients receiving placebo (n = 4) showed no significant change in serum IgG concentration (mean change + 10% (SEM 5.3%]. Asthmatic patients treated with ketoconazole (n = 4) had significantly lower symptom scores than those receiving placebo (n = 3) (+0.45%/month (SEM 6.9%) versus +27%/month (SEM 6.5%); p less than 0.001). None of the patients treated with ketoconazole reported any adverse effects. Ketoconazole may cause serious liver damage but its use may be justified in bronchopulmonary aspergillosis if further experience confirms its ability to alter the course of a potentially serious disease.

RCT Entities:   Population Interventions Outcomes