A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Prednisolone: Prednisolone for 4 months
Itraconazole: SUBA-itraconazole for 4 months
Study summary
The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy.
In this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.
Eligibility
Primary outcome measure(s)
- Asthma or ABPA exacerbations — 12 months after treatment completion
Proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chest Clinic, Dept. of Pulmonary Medicine | Chandigarh | Chandigarh | Recruiting |
More Post Graduate Institute of Medical Education and Research, Chandigarh trials in India
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06174922 on ClinicalTrials.gov ↗ ← All trials in India