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

• remission rates in the two groups at six weeks and three months [ Time Frame: one year ] [ Designated as safety issue: No ]
• percentage decline in IgE levels at six weeks and three months [ Time Frame: one year ] [ Designated as safety issue: No ]
• complete remission rates in the two groups [ Time Frame: one year ] [ Designated as safety issue: No ]

• relapse rates in the two groups at six and 12 months after completion of glucocorticoid therapy [ Time Frame: two years ] [ Designated as safety issue: No ]
• glucocorticoid related adverse effects in the two groups [ Time Frame: two years ] [ Designated as safety issue: No ]

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.

• 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

• Active Comparator: Low-dose glucocorticoid
  Low-dose steroid
  Intervention: Drug: Glucocorticoids
• Active Comparator: High-dose glucocorticoid
  High-dose steroid
  Intervention: Drug: Glucocorticoids

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