RecruitingNot ApplicableNCT05444946

Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome

A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome


Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Enrollment

104 participants

Start Date

Jun 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.


Eligibility

Min Age: 15 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral itraconazole and a drug called Prednisone tablet and Itraconazole for people with allergic bronchopulmonary aspergillosis and chronic pulmonary aspergillosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 15 Years to 90 Years.

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

DRUGPrednisone tablet and Itraconazole

Oral prednisolone 0.5 mg/Kg body weight tapered over 4 months and oral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. traconazole will be given for 12 months

DRUGOral itraconazole

Oral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. Itraconazole will be given for 12 months


Locations(2)

Chest clinic

Chandigarh, Chandigarh, India

Chest clinic, PGIMER

Chandigarh, India

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NCT05444946


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