Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

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

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborator: Cipla Ltd.
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Voriconazole

Criteria

Inclusion Criteria:

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 kUA/L

And, two of the following criteria:

• Presence of serum precipitating antibodies against A fumigatus

• Fixed or transient radiographic pulmonary opacities

• Total eosinophil count > 1000/µL

• Central bronchiectasis on HRCT

Exclusion Criteria:

• Failure to give informed consent

• Intake of glucocorticoids for more than three weeks in the preceding six months

• Enrollment in another trial of ABPA

• Any exposure to azoles in the last six months