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A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03133299
Enrollment
30
Registered
2017-04-28
Start date
2016-12-01
Completion date
2018-06-30
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Bronchopulmonary Aspergilloses

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.

Interventions

DRUGGlucocorticoids

Oral prednisolone for four months

DRUGVitamin D

Oral vitamin D for two months

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decline in total IgETwo monthsTotal IgE at baseline and two months

Secondary

MeasureTime frameDescription
Decline in total IgEFour monthsTotal IgE at baseline and four months
Th1/Th2 cytokinesTwo monthsTh1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months
Time to first exacerbationOne yearThe time to first exacerbation will be noted in the two groups

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026