A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Glucocorticoid group 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 |
Drug: Glucocorticoids
Oral prednisolone for four months
|
| Experimental: Vitamin D plus Glucocorticoid group 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 |
Drug: Glucocorticoids
Oral prednisolone for four months
Drug: Vitamin D
Oral vitamin D for two months
|
Outcome Measures
Primary Outcome Measures
- Decline in total IgE [Two months]
Total IgE at baseline and two months
Secondary Outcome Measures
- Decline in total IgE [Four months]
Total IgE at baseline and four months
- Decline in total IgE [Six months]
Total IgE at baseline and six months
- Th1/Th2 cytokines [Two months]
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months
- Th1/Th2 cytokines [Four months]
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and four months
- Th1/Th2 cytokines [Six months]
Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and six months
- Time to first exacerbation [One year]
The time to first exacerbation will be noted in the two groups
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Postgraduate Institute of Medical Education and Research | Chandigarh | India | 160012 |
Sponsors and Collaborators
- Postgraduate Institute of Medical Education and Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pulm.Med/2017/002