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

Primary Purpose

Allergic Bronchopulmonary Aspergillosis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Glucocorticoids
Glucocorticoids
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis focused on measuring bronchial asthma, allergic bronchopulmonary aspergillosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-dose glucocorticoid

High-dose glucocorticoid

Arm Description

Low-dose steroid

High-dose steroid

Outcomes

Primary Outcome Measures

Glucocorticoid-dependent ABPA
relapse rates in the two groups

Secondary Outcome Measures

time to first relapse
glucocorticoid related adverse effects in the two groups
response rates in the two groups

Full Information

First Posted
September 9, 2009
Last Updated
February 22, 2015
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00974766
Brief Title
Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
Official Title
Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchopulmonary Aspergillosis
Keywords
bronchial asthma, allergic bronchopulmonary aspergillosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose glucocorticoid
Arm Type
Active Comparator
Arm Description
Low-dose steroid
Arm Title
High-dose glucocorticoid
Arm Type
Active Comparator
Arm Description
High-dose steroid
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Intervention Description
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
Primary Outcome Measure Information:
Title
Glucocorticoid-dependent ABPA
Time Frame
two year
Title
relapse rates in the two groups
Time Frame
one year
Secondary Outcome Measure Information:
Title
time to first relapse
Time Frame
one year
Title
glucocorticoid related adverse effects in the two groups
Time Frame
two years
Title
response rates in the two groups
Time Frame
six weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ABPA Presence of all the following three criteria: immediate cutaneous hyperreactivity on aspergillus skin test elevated total IgE levels > 1000 IU/mL A fumigatus specific IgE levels > 0.35 kU/L, AND, Presence of two of the following criteria: presence of serum precipitating antibodies against A fumigatus fixed or transient radiographic pulmonary opacities absolute eosinophil count > 1000/µL 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD, DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research, Chandigarh, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26585431
Citation
Agarwal R, Aggarwal AN, Dhooria S, Singh Sehgal I, Garg M, Saikia B, Behera D, Chakrabarti A. A randomised trial of glucocorticoids in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Eur Respir J. 2016 Feb;47(2):490-8. doi: 10.1183/13993003.01475-2015. Epub 2015 Nov 19.
Results Reference
derived

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

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