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A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

Primary Purpose

Allergic Bronchopulmonary Aspergilloses

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Glucocorticoids
Vitamin D
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Bronchopulmonary Aspergilloses

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Glucocorticoid group

Vitamin D plus Glucocorticoid group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Decline in total IgE
Total IgE at baseline and two months

Secondary Outcome Measures

Decline in total IgE
Total IgE at baseline and four months
Decline in total IgE
Total IgE at baseline and six months
Th1/Th2 cytokines
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months
Th1/Th2 cytokines
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and four months
Th1/Th2 cytokines
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and six months
Time to first exacerbation
The time to first exacerbation will be noted in the two groups

Full Information

First Posted
April 21, 2017
Last Updated
August 22, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03133299
Brief Title
A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
Official Title
A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchopulmonary Aspergilloses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucocorticoid group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Vitamin D plus Glucocorticoid group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Intervention Description
Oral prednisolone for four months
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Oral vitamin D for two months
Primary Outcome Measure Information:
Title
Decline in total IgE
Description
Total IgE at baseline and two months
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Decline in total IgE
Description
Total IgE at baseline and four months
Time Frame
Four months
Title
Decline in total IgE
Description
Total IgE at baseline and six months
Time Frame
Six months
Title
Th1/Th2 cytokines
Description
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months
Time Frame
Two months
Title
Th1/Th2 cytokines
Description
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and four months
Time Frame
Four months
Title
Th1/Th2 cytokines
Description
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and six months
Time Frame
Six months
Title
Time to first exacerbation
Description
The time to first exacerbation will be noted in the two groups
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30561849
Citation
Dodamani MH, Muthu V, Thakur R, Pal A, Sehgal IS, Dhooria S, Aggarwal AN, Garg M, Chakrabarti A, Agarwal R. A randomised trial of vitamin D in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Mycoses. 2019 Apr;62(4):320-327. doi: 10.1111/myc.12879. Epub 2019 Feb 5.
Results Reference
derived

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A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

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