Allergic Bronchopulmonary Aspergillosis
Conditions
Keywords
bronchial asthma, allergic bronchopulmonary aspergillosis
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.
Interventions
DRUGGlucocorticoids
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
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucocorticoid-dependent ABPA | two year |
| relapse rates in the two groups | one year |
Secondary
| Measure | Time frame |
|---|---|
| time to first relapse | one year |
| glucocorticoid related adverse effects in the two groups | two years |
| response rates in the two groups | six weeks |
Countries
India
Outcome results
None listed