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

Phase 2

Completed

• Conditions: Allergic Bronchopulmonary Aspergillosis
• Interventions: Drug: Glucocorticoids

• Registration Number: NCT00974766
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-22
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-dose glucocorticoid	Glucocorticoids	High-dose steroid
Low-dose glucocorticoid	Glucocorticoids	Low-dose steroid

Primary Outcome Measures

Name	Time	Method
Glucocorticoid-dependent ABPA	two year
relapse rates in the two groups	one year

Secondary Outcome Measures

Name	Time	Method
time to first relapse	one year
glucocorticoid related adverse effects in the two groups	two years
response rates in the two groups	six weeks

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India