Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
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.
Official title: A Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients with Acute Stage of Allergic Bronchopulmonary Aspergillosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-12-01
Completion Date
2026-06
Last Updated
2025-02-28
Healthy Volunteers
No
Conditions
Interventions
Prednisolone
Prednisolone for 4 months
Itraconazole
SUBA-itraconazole for 4 months
Locations (1)
Chest Clinic, Dept. of Pulmonary Medicine
Chandigarh, Chandigarh, India