RecruitingPhase 3NCT06174922

A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis

A Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients with Acute Stage of Allergic Bronchopulmonary Aspergillosis


Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Enrollment

300 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Itraconazole and a drug called Prednisolone for people with allergic bronchopulmonary aspergillosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisolone

Prednisolone for 4 months

DRUGItraconazole

SUBA-itraconazole for 4 months


Locations(1)

Chest Clinic, Dept. of Pulmonary Medicine

Chandigarh, Chandigarh, India

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NCT06174922


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