Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of itraconazole monotherapy in patients with ABPA.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Fluticasone; Formoterol Fumarate; Glucocorticoids; Hydroxyitraconazole; Itraconazole; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria: Patients will be included in the study if they meet the criteria for ABPA defined by

Presence of all the following three criteria:

• immediate cutaneous hyperreactivity on aspergillus skin test

• elevated total IgE levels > 1000 IU/mL

• A fumigatus specific IgE levels > 0.35 kU/L

Two of the following criteria:

• presence of serum precipitating antibodies against A fumigatus

• fixed or transient radiographic pulmonary opacities

• absolute eosinophil count > 1000/µL

• central bronchiectasis on HRCT.

Exclusion Criteria:

• if they have taken glucocorticoids for more than three weeks in the preceding six months

• failure to give informed consent

• enrollment in another trial of ABPA