Actively Recruiting
Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2026-04-07
104
Participants Needed
2
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 15 and 90 years
- Meet diagnostic criteria for both allergic bronchopulmonary aspergillosis (ABPA) and chronic pulmonary aspergillosis (CPA)
- For CPA: symptoms like cough, hemoptysis, weight loss, malaise, fever, or dyspnea for 3 months or more
- Radiological signs on chest CT showing cavities, fibrosis, infiltrates, consolidation, fungal ball, or pleural thickening
- Laboratory evidence of Aspergillus infection by specific IgG, Aspergillus precipitins, or growth in respiratory samples
- For ABPA: A.fumigatus-specific IgE over 0.35 kUA/L
- Total IgE of 500 IU/mL or higher
- Eosinophil count of 500 cells/µL or higher
- A.fumigatus-specific IgG over 27 mgA/L
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Use of immunosuppressive drugs or prednisolone equivalent over 10 mg daily for at least 3 weeks
- Diagnosis of HIV infection
- Use of antifungal triazoles for more than 3 weeks in the past 3 months
- Active lung infection with tuberculosis or other mycobacteria
- Other forms of pulmonary aspergillosis such as subacute or acute invasive aspergillosis
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chest clinic
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
2
Chest clinic, PGIMER
Chandigarh, India, 160012
Active, Not Recruiting
Research Team
I
Inderpaul S Sehgal, MD, DM
CONTACT
R
Ritesh Agarwal, MD,DM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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