Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis (MIPA)
Allergic Bronchopulmonary Aspergillosis
About this trial
This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis focused on measuring ABPA
Eligibility Criteria
Inclusion Criteria: Patients will be included in the study if they meet the criteria for ABPA defined by
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
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
Sites / Locations
- Postgraduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Itraconazole group
Glucocorticoid group
Itraconazole 200 mg BD for 4 months along with inhaled formoterol/fluticasone (6/125 mcg) 2 puffs twice daily by MDI and as needed as per the SMART approach
Prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 2 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) as needed as per the SMART approach for control of asthma