A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

NCT03133299 | Completed Phase 2 DMC

• 1 other identifier: Pulm.Med/2017/002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Bronchopulmonary Aspergilloses

Outcome Measures

Primary Outcomes (1)

• Decline in total IgE

  Total IgE at baseline and two months

  Two months

Secondary Outcomes (6)

• Decline in total IgE

  Four months

• Decline in total IgE

  Six months

• Th1/Th2 cytokines

  Two months

• Th1/Th2 cytokines

  Four months

• Th1/Th2 cytokines

  Six months

Study Arms (2)

Glucocorticoid group

ACTIVE COMPARATOR

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

Vitamin D plus Glucocorticoid group

EXPERIMENTAL

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; Drug: Vitamin D

Interventions

Glucocorticoids DRUG

Oral prednisolone for four months

Glucocorticoid group; Vitamin D plus Glucocorticoid group

Vitamin D DRUG

Oral vitamin D for two months

Vitamin D plus Glucocorticoid group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ABPA as per the International Society for Human and Animal Mycology Working group criteria
• Treatment naïve

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

• Dodamani MH, Muthu V, Thakur R, Pal A, Sehgal IS, Dhooria S, Aggarwal AN, Garg M, Chakrabarti A, Agarwal R. A randomised trial of vitamin D in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Mycoses. 2019 Apr;62(4):320-327. doi: 10.1111/myc.12879. Epub 2019 Feb 5.

  PMID: 30561849 DERIVED

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

Glucocorticoids; Vitamin D

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Pulmonary Medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 28, 2017
• Study Start: December 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

IN (1)