Comparing oral itraconazole alone versus with glucocorticoids for lung disease overlap
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
This study tests whether taking oral itraconazole alone or with glucocorticoids helps people with both Chronic Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 15 Years to 90 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 2 sites (Chandigarh, Chandigarh and 1 other locations) |
| Trial ID | NCT05444946 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical outcomes of patients with Chronic Pulmonary Aspergillosis (CPA) and Allergic Bronchopulmonary Aspergillosis (ABPA) overlap syndrome. It compares the effectiveness of oral itraconazole alone against a combination of systemic glucocorticoids and oral itraconazole. The research focuses on patients who meet specific diagnostic criteria for both conditions, assessing their symptoms and response to treatment. The goal is to determine the most effective management protocol for this overlap group.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with both Chronic Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis.
Not a fit: Patients who do not have the overlap of CPA and ABPA or those with other unrelated pulmonary disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from overlapping CPA and ABPA, enhancing their quality of life.
How similar studies have performed: While there is limited data on this specific overlap treatment approach, previous studies have shown varying success in managing CPA and ABPA separately, indicating potential for this novel exploration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chandigarh, Chandigarh and 1 other locations
- Chest clinic — Chandigarh, Chandigarh, India (Recruiting)
- Chest clinic, PGIMER — Chandigarh, India (Active_not_recruiting)
Study contacts
- Study coordinator: Inderpaul S Sehgal, MD, DM
- Email: inderpgi@outlook.com
- Phone: 91-172275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.