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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
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
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
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, India
Glucocorticoid-dependent ABPA
Time frame: two year
relapse rates in the two groups
Time frame: one year
time to first relapse
Time frame: one year
glucocorticoid related adverse effects in the two groups
Time frame: two years
response rates in the two groups
Time frame: six weeks
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