Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome (GLITZ)
Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
About this trial
This is an interventional treatment trial for Chronic Pulmonary Aspergillosis
Eligibility Criteria
Inclusion Criteria:
Subjects fulfil criteria for ABPA and CPA as below.
The criteria for CPA would include the presence of all the following: (i) one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months; (ii) slowly progressive or persistent findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax; (iii) immunological (A.fumigatus-specific IgG >27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions) and, (iv) exclusion of other pulmonary disorders with similar presentation.
The diagnosis of ABPA will be made based on the presence of all the following: (a) A.fumigatus specific IgE >0.35 kUA/L; (b) total IgE ≥500 IU/mL; (c) eosinophil count ≥500 cells/µL); (d) A.fumigatus IgG>27 mgA/L.
Exclusion Criteria:
(i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of prednisolone (or equivalent) >10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome; (iii) intake of antifungal triazoles for >3 weeks in the preceding three months; (iv) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (v) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); and, (vi) pregnancy.
Sites / Locations
- Chest clinic, PGIMER
- Chest clinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Steroid itraconazole
Itraconazole
Combination of oral glucocorticoid (prednisolone 0.5 mg/Kg body weight tapered over 4 months) and itraconazole for 12 months
Oral itraconazole for 12 months