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

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergic Bronchopulmonary Aspergillosis

Intervention / Treatment
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* Drug: Glucocorticoids
* Drug: Glucocorticoids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ABPA Presence of all the following three criteria: immediate cutaneous hyperreactivity on aspergillus skin test elevated total IgE levels > 1000 IU/mL A fumigatus specific IgE levels > 0.35 kU/L, AND, Presence of two of the following criteria: presence of serum precipitating antibodies against A fumigatus fixed or transient radiographic pulmonary opacities absolute eosinophil count > 1000/µL 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-dose glucocorticoid<br>Low-dose steroid | Drug: Glucocorticoids<br>* 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<br>|
| Active Comparator: High-dose glucocorticoid<br>High-dose steroid | Drug: Glucocorticoids<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucocorticoid-dependent ABPA |  | two year | 
| relapse rates in the two groups |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchial asthma, allergic bronchopulmonary aspergillosis