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ACTIVE NOT RECRUITING
NCT04227483
PHASE2/PHASE3

Deflazacort Vs. Prednisolone in Acute-stage ABPA

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial of Deflazacort Vs. Prednisolone in Acute-stage Allergic Bronchopulmonary Aspergillosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2020-01-15

Completion Date

2025-07

Last Updated

2025-02-28

Healthy Volunteers

No

Interventions

DRUG

Deflazacort

Deflazacort for 4 months

DRUG

Prednisolone

Prednisolone for 4 months

Locations (1)

Chest Clinic, Dept. of Pulmonary Medicine

Chandigarh, Chandigarh, India