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Deflazacort Vs. Prednisolone in Acute-stage ABPA

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Primary and study completion dates: Dec 2024 to Jul 2025
    • Site details revised
    v6
  2. Primary completion date: Dec 2022 to Dec 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2023 to Dec 2024
    • Site details revised
    v5
  3. Primary completion date: Jan 14, 2022 to Dec 2022
    • Study completion date: Jun 15, 2022 to Jun 2023
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study description expanded, about 4 words
    • Study title shortened, about 3 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04227483
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions
(from sponsor)		 Allergic Bronchopulmonary Aspergillosis
Related terms Aspergillosis, Allergic Bronchopulmonary, Asthma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov