Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

February 22, 2015 updated by: Ritesh Agarwal, Postgraduate Institute of Medical Education and Research

Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.

The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of ABPA

  • Presence of all the following three criteria:

    1. immediate cutaneous hyperreactivity on aspergillus skin test
    2. elevated total IgE levels > 1000 IU/mL
    3. A fumigatus specific IgE levels > 0.35 kU/L, AND,

  • Presence of two of the following criteria:

    1. presence of serum precipitating antibodies against A fumigatus
    2. fixed or transient radiographic pulmonary opacities
    3. absolute eosinophil count > 1000/µL
    4. central bronchiectasis on HRCT

Exclusion Criteria:

  • If they have taken glucocorticoids for more than three weeks in the preceding six months
  • Failure to give informed consent
  • Enrollment in another trial of ABPA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Low-dose glucocorticoid
Low-dose steroid
Drug: Glucocorticoids
Prednisolone 0.5 mg/kg/day for 2 weeks; then 0.5 mg/kg/day for alternate days for eight weeks. Then taper by 5 mg every 2 weeks and discontinue
Drug: Glucocorticoids
Prednisolone 0.75 mg/kg/day for 6 weeks; then 0.5 mg/kg/day for 6 weeks. Then taper by 5 mg every 6 weeks and discontinue
ACTIVE_COMPARATOR: High-dose glucocorticoid
High-dose steroid
Drug: Glucocorticoids
Prednisolone 0.5 mg/kg/day for 2 weeks; then 0.5 mg/kg/day for alternate days for eight weeks. Then taper by 5 mg every 2 weeks and discontinue
Drug: Glucocorticoids
Prednisolone 0.75 mg/kg/day for 6 weeks; then 0.5 mg/kg/day for 6 weeks. Then taper by 5 mg every 6 weeks and discontinue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucocorticoid-dependent ABPA
Time Frame: two year
two year
relapse rates in the two groups
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
time to first relapse
Time Frame: one year
one year
glucocorticoid related adverse effects in the two groups
Time Frame: two years
two years
response rates in the two groups
Time Frame: six weeks
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Ritesh Agarwal, MD, DM, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (ESTIMATE)

September 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 22, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS/723/Res/276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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