Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With CPA
Status:
Completed
Trial end date:
2021-08-15
Target enrollment:
Participant gender:
Summary
The treatment options majorly consist of medical management with at least 6-month long
treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the
preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole
remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable
overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects
have disease relapse that requires prolonged therapy. It is likely that a longer duration of
itraconazole would have a higher response rate and thus, lower risk of relapse after
discontinuation of therapy. In this randomized controlled trial, we compare the clinical
outcomes of six months versus twelve months of itraconazole therapy in treatment naïve
subjects with chronic pulmonary aspergillosis
Phase:
Phase 3
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research