Allergic Bronchopulmonary Aspergillosis Clinical Trial
— GLITZOfficial title:
A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome
While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Chest clinic | Chandigarh | |
India | Chest clinic, PGIMER | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Favourable response at six months after the randomization | Proportion of subjects with an overall favourable response at six months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease | 6 months after randomization | |
Secondary | Overall favourable response at 12 months after randomization | Proportion of subjects with an overall favourable response at 12 months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease | 12 months after randomization | |
Secondary | frequency of relapses at 18-months after randomization | Relapse: will be defined as persistent worsening of symptoms (for 14 days or more) as measured by VAS and radiological worsening. The subjects will be investigated for other causes of worsening such as bacterial infection or reinfection/reactivation of tuberculosis before labelling the worsening due to relapse of CPA. A relapse will be defined as an event that occurs 3 months after stopping treatment | 18 months after randomization | |
Secondary | adverse events in either arm | Adverse events due to systemic glucocorticoids and oral itraconazole will be assessed at 2 weeks after treatment initiation and then at 3 months interval till treatment completion | 12 months after randomization | |
Secondary | Serum total IgE response to treatment | proportion of subjects with 25% reduction in serum IgE at 6 weeks after treatment initiation | 6 weeks after treatment initiation | |
Secondary | Serum total IgE during relapse | Proportion of subjects with 50% increase in serum IgE during relapse | 18 months after randomization |
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