ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Aspergillosis"

A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03133299
Recruitment Status : Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research

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
Allergic Bronchopulmonary Aspergilloses Drug: Glucocorticoids Drug: Vitamin D 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


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




Primary Outcome Measures :
  1. Decline in total IgE [ Time Frame: Two months ]
    Total IgE at baseline and two months


Secondary Outcome Measures :
  1. Decline in total IgE [ Time Frame: Four months ]
    Total IgE at baseline and four months

  2. Decline in total IgE [ Time Frame: Six months ]
    Total IgE at baseline and six months

  3. Th1/Th2 cytokines [ Time Frame: Two months ]
    Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and two months

  4. Th1/Th2 cytokines [ Time Frame: Four months ]
    Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and four months

  5. Th1/Th2 cytokines [ Time Frame: Six months ]
    Th1 (IL-2 and interferon-gamma) and Th2 (IL4, IL5, IL10) cytokines at baseline and six months

  6. Time to first exacerbation [ Time Frame: One year ]
    The time to first exacerbation will be noted in the two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133299


Contacts
Contact: Ritesh Agarwal, MD, DM 0172-2756825 agarwal.ritesh@outlook.in
Contact: Ashutosh N Aggarwal, MD, DM 0172-2756824 aggarwal.ashutosh@outlook.com

Locations
India
Postgraduate Institute of Medical Education and Research Not yet recruiting
Chandigarh, India, 160012
Contact: Ritesh Agarwal, MD, DM    0172-2756825    agarwal.ritesh@outlook.in   
Contact: Ashutosh Aggarwal, MD, DM    0172-2756824    aggarwal.ashutosh@outlook.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Responsible Party: Ritesh Agarwal, Consultant, Department of Pulmonary Medicine, Principal Investigator, Clinical Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03133299     History of Changes
Other Study ID Numbers: Pulm.Med/2017/002
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Prednisolone
Glucocorticoids
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents