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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Bronchopulmonary Aspergillosis

Treatments: Drug: Glucocorticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT00974766

MS/723/Res/276

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Low-dose glucocorticoid

Active Comparator group

Description:

Low-dose steroid

Treatment:

Drug: Glucocorticoids

Drug: Glucocorticoids

High-dose glucocorticoid

Active Comparator group

Description:

High-dose steroid

Treatment:

Drug: Glucocorticoids

Drug: Glucocorticoids