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

NCT00974766 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2015-02-24

No results posted yet for this study

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.

Conditions

  • Allergic Bronchopulmonary Aspergillosis

Interventions

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Ritesh Agarwal, MD, DM · Postgraduate Institute of Medical Education and Research, Chandigarh, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974766 on ClinicalTrials.gov