A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-06-30

Brief Summary

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Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treating ABPA.

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Detailed Description

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Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease.

Systemic steroids remain the mainstay of treatment in ABPA. Antifungal agents are also useful as they reduce fungal load. Newer therapies like omalizumab (anti immunoglobulin E \[IgE\] antibody), inhalational amphotericin and Anti Th2 therapies are being studied.

In pathogenesis of ABPA, there is heightened Th2 activity as a result of type 1 hypersensitive reaction to Aspergillus fumigatus and levels of Th2 cytokines like IL-3, IL-5 and IL-13 and IgE levels are increased in patients with ABPA compared with asthma patients without ABPA.

Recently anti Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 immunity and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treatment of ABPA.

Conditions

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Allergic Bronchopulmonary Aspergilloses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glucocorticoid group

Oral prednisolone 0.5 mg/kg/day for four weeks, 0.25 mg/kg/day for four weeks followed by 0.125 mg/kg/day for four weeks. Prednisolone will then be tapered by 5 mg every two weeks and discontinued. The total duration of glucocorticoids will be four months

Group Type ACTIVE_COMPARATOR

Glucocorticoids

Intervention Type DRUG

Oral prednisolone for four months

Vitamin D plus Glucocorticoid group

Oral vitamin D3 tablet, 60,000 IU weekly for 2 months (8 doses) along with Oral prednisolone 0.5 mg/kg/day for four weeks, 0.25 mg/kg/day for four weeks followed by 0.125 mg/kg/day for four weeks. Prednisolone will then be tapered by 5 mg every two weeks and discontinued. The total duration of glucocorticoids will be four months

Group Type EXPERIMENTAL

Glucocorticoids

Intervention Type DRUG

Oral prednisolone for four months

Vitamin D

Intervention Type DRUG

Oral vitamin D for two months

Interventions

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Glucocorticoids

Oral prednisolone for four months

Intervention Type DRUG

Vitamin D

Oral vitamin D for two months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ABPA as per the International Society for Human and Animal Mycology Working group criteria
* Treatment naïve

Exclusion Criteria

* Failure to provide informed consent
* Enrollment in another trial of ABPA
* Pregnancy
* Creatinine more than or equal to 1.5 mg/dL
* Immunosuppressive states like chronic liver disease, chronic renal failure, cytotoxic therapy, uncontrolled diabetes mellitus and others

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No