Comparing oral itraconazole alone versus with glucocorticoids for lung disease overlap

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-based ABPA recurrence predictor in adults with ABPA

  A machine-learning model is being tested to see if it can predict the chance of an ABPA flare within a year in adults with ABPA during a stable phase.

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• Fungal status and prognosis in ABPA: looking at who improves based on fungal tests

  This study checks if ABPA patients with positive or negative fungal tests in sputum or BALF have different outcomes over a year.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07690345

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Biologic treatment for adults with ABPA and severe asthma

  This project will test whether biologic medicines help adults with ABPA who have severe asthma and elevated eosinophils.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362693

• Bronchoscopic airway clearance with amphotericin B spraying for ABPA

  This study will try bronchoscopic airway clearance plus amphotericin B spraying to see if it helps adults with allergic bronchopulmonary aspergillosis (ABPA) who have mucus plugs.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362667

• Assessing the impact of Chronic Pulmonary Aspergillosis on health and well-being

  This study is trying to create a new questionnaire to help understand how Chronic Pulmonary Aspergillosis affects the daily lives of patients.

  Recruiting at 3 sites Imperial College London · Dundee and 2 other locations · NCT06885905

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.