NCT04227483

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

5.5 years

First QC Date

January 10, 2020

Last Update Submit

February 26, 2025

Conditions

Allergic Bronchopulmonary Aspergillosis

Keywords

ABPAAsthmaGlucocorticoids

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    Weight at 2 months minus the baseline weight

    2 months

Secondary Outcomes (8)

  • Decline in serum total IgE levels

    2 months

  • Decline in serum total IgE levels

    4 months

  • Response rates

    2 months

  • Response rates

    4 months

  • Exacerbation rates

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Prednisolone

ACTIVE COMPARATOR

Prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 2 weeks and discontinue. All doses will be rounded off to the nearest 5 mg (maximum duration of therapy, 4 months)

Drug: Prednisolone

Deflazacort

EXPERIMENTAL

Deflazacort 0.75 mg/kg/day for 4 weeks; 0.375 mg/kg/day for 4 weeks; 0.1875 mg/kg/day for 4 weeks. Then taper by 6 mg every 2 weeks and discontinue. All doses will be rounded off to the nearest 6 mg (maximum duration of therapy, 4 months)

Drug: Deflazacort

Interventions

DeflazacortDRUG

Deflazacort for 4 months

Deflazacort
PrednisoloneDRUG

Prednisolone for 4 months

Prednisolone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Clinic, Dept. of Pulmonary Medicine

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Aspergillosis, Allergic BronchopulmonaryAsthma

Interventions

deflazacortPrednisolone

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchial DiseasesLung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 13, 2020

Study Start

January 15, 2020

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)