Deflazacort vs. Prednisolone in Acute-stage ABPA

• Status: Recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Deflazacort; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

Patients aged 18-65 years will be included in the study if they meet the modified ISHAM-ABPA working group criteria defined by the presence of all the following three criteria:

• Asthma

• A.fumigatus-specific IgE levels > 0.35 kUA/L

• Elevated serum total IgE levels > 1000 IU/mL; and two of the following criteria:

• Presence of elevated A fumigatus-specific IgG >27 mgA/L;

• Radiographic pulmonary opacities consistent with ABPA

• Peripheral blood eosinophil count >500/µL.

Exclusion Criteria:

• Taken any prior treatment for ABPA (systemic glucocorticoids, antifungal drugs)

• Failure to give informed consent

• Enrollment in another trial of ABPA

• Pregnancy

• Any of the following comorbidity: diabetes mellitus, glaucoma, chronic liver disease and chronic kidney disease