Clinical Trial: A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

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 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.

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.


Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: Decline in total IgE [ Time Frame: Two months ]

Total IgE at baseline and two months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decline in total IgE [ Time Frame: Four months ]
    Total IgE at baseline and four months
  • Decline in total IgE [ Time Frame: Six months ]
    Total IgE at baseline and six months
  • Th1/Th2 cytokines [ Time Frame: Two months ]
    Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months
  • Th1/Th2 cytokines [ Time Frame: Four months ]
    Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and four months
  • Th1/Th2 cytokines [ Time Frame: Six months ]
    Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and six months
  • Time to first exacerbation [ Time Frame: One year ]
    The time to first exacerbation will be noted in the two groups


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: April 21, 2017
Date Started: May 2017
Date Completion: December 2018
Last Updated: April 27, 2017
Last Verified: April 2017