Postgraduate Institute of Medical Education and Research
Chandigarh, 160012, India
NCT Number: NCT03133299
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Chandigarh, 160012, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral prednisolone for four months
Oral vitamin D for two months
Time frame: Two months
Total IgE at baseline and two months
Time frame: Four months
Total IgE at baseline and four months
Time frame: Six months
Total IgE at baseline and six months
Time frame: Two months
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months
Time frame: Four months
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and four months
Time frame: Six months
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and six months
Time frame: One year
The time to first exacerbation will be noted in the two groups
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
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