Allergic Bronchopulmonary Aspergilloses
Conditions
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
Oral prednisolone for four months
Oral vitamin D for two months
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Decline in total IgE | Two months | Total IgE at baseline and two months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decline in total IgE | Four months | Total IgE at baseline and four months |
| Th1/Th2 cytokines | Two months | Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months |
| Time to first exacerbation | One year | The time to first exacerbation will be noted in the two groups |
Countries
India