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

Allergic Bronchopulmonary Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974766
• Other study ID #: MS/723/Res/276
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2009
• Last updated: February 22, 2015
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Pulmonary Aspergillosis

Intervention

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
• 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

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucocorticoid-dependent ABPA		two year	No
Primary	relapse rates in the two groups		one year	No
Secondary	time to first relapse		one year	No
Secondary	glucocorticoid related adverse effects in the two groups		two years	No
Secondary	response rates in the two groups		six weeks	No