Clinical Trial

Deflazacort Vs. Prednisolone in Acute-stage ABPA

Active, Not Recruiting Phase 2/3
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Record status
This record was last updated February 28, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
Oral glucocorticoids are currently the treatment of choice for allergic bronchopulmonary aspergillosis (ABPA). They not only suppress the immune hyperfunction but are also anti-inflammatory. Unfortunately, numerous toxicities and adverse effects have been attributed to glucocorticoids related to both the average dose and cumulative duration of use. Deflazacort is a oxazoline steroid with demonstrated anti-inflammatory and immunosuppressant effects. The novel structural characteristic of deflazacort is associated with substantial lack of sodium-retaining activity, lower interference with carbohydrate metabolism and calcium metabolism in comparison with older glucocorticoids such as prednisolone. The investigators hypothesize that the occurrence of side-effects, primarily weight gain will be lower with deflazacort. In this study, the investigators will compare the safety and efficacy of deflazacort in the treatment of acute-stage ABPA complicating asthma.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-01-10; most recent amendment 2025-02-26.
Status change: Recruiting → Active, Not Recruiting 2023-11-24
Trial Details
NCT Number NCT04227483
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions Allergic Bronchopulmonary Aspergillosis
Enrollment 150 participants
Start Date 2020-01-15
Primary Completion 2025-07 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-28