drugset / Trial / NCT04227483

Deflazacort Vs. Prednisolone in Acute-stage ABPA

NCT04227483

Phase 2/3 Active not recruiting 150 enrolled Post Graduate Institute of Medical Education and Research, Chandigarh
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-01-15
Primary completion
2025-07
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Deflazacort Other / unclassified 0.1875 mg/kg Oral
Comparator Prednisolone Other / unclassified 0.125 mg/kg Oral