NCT00974766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

September 9, 2009

Last Update Submit

February 22, 2015

Conditions

Allergic Bronchopulmonary Aspergillosis

Keywords

bronchial asthmaallergic bronchopulmonary aspergillosis

Outcome Measures

Primary Outcomes (2)

  • Glucocorticoid-dependent ABPA

    two year

  • relapse rates in the two groups

    one year

Secondary Outcomes (3)

  • time to first relapse

    one year

  • glucocorticoid related adverse effects in the two groups

    two years

  • response rates in the two groups

    six weeks

Study Arms (2)

Low-dose glucocorticoid

ACTIVE COMPARATOR

Low-dose steroid

Drug: Glucocorticoids

High-dose glucocorticoid

ACTIVE COMPARATOR

High-dose steroid

Drug: Glucocorticoids

Interventions

GlucocorticoidsDRUG

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

Low-dose glucocorticoid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (1)

  • 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.

    PMID: 26585431DERIVED

MeSH Terms

Conditions

Aspergillosis, Allergic BronchopulmonaryAsthma

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchial DiseasesLung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Ritesh Agarwal, MD, DM

    Postgraduate Institute of Medical Education and Research, Chandigarh, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

IN(1)