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Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
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.
Official title: 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
Key Details
Gender
All
Age Range
15 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2022-06-15
Completion Date
2027-02-01
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Prednisone 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
Oral 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