Actively Recruiting

Phase Not Applicable
Age: 15Years - 90Years
All Genders
NCT05444946

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

Age: 15Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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