Comparing Prednisolone and Itraconazole for Allergic Bronchopulmonary Aspergillosis

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 clinical trial investigates the effectiveness of prednisolone, itraconazole, and their combination in treating patients with acute allergic bronchopulmonary aspergillosis (ABPA). A total of 300 participants aged 18 and older will be randomized to receive one of the three treatments for four months. The study aims to assess the rate of exacerbations in these patients over a 12-month period following treatment. Participants will be monitored through regular follow-ups to collect data on their health status and treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Consecutive subjects of acute stage allergic bronchopulmonary aspergillosis (ABPA) complicating asthma per the revised ISHAM-ABPA working group criteria

* newly diagnosed subjects with uncontrolled asthma or symptoms or radiology suggesting active lesions attributable to ABPA and meeting the diagnostic criteria of ABPA
* those previously meeting the diagnostic criteria for ABPA and presenting with sustained (≥2 weeks) clinical or radiological worsening; and increase in serum total IgE by ≥50% of the last recorded IgE value during clinical stability.

Exclusion Criteria:

* occurrence of ≥3 ABPA exacerbations in the last 18 months before enrollment
* contraindications to the use of either prednisolone or itraconazole
* subjects who have received oral prednisolone (or equivalent) ≥30 mg for ≥2 weeks or itraconazole (or voriconazole or posaconazole or isavuconazole) for more than 2 weeks, in the last 3 months
* chronic medical illnesses, including uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure, chronic heart failure, and others
* patient on immunosuppressive drugs
* pregnancy
* enrollment in another trial of ABPA
* failure to provide informed consent
* asthma exacerbation: worsening respiratory symptoms for at least 24 hours without immunological or radiological deterioration of ABPA
* infective/bronchiectasis exacerbation: clinical deterioration for at least 24 hours with increase in cough; breathlessness; sputum volume or consistency; sputum purulence; fatigue, malaise, or fever; and hemoptysis without immunological or radiological deterioration of ABPA
* serologic ABPA

Where it's running

• Chest Clinic, Dept. of Pulmonary Medicine
  Chandigarh, Chandigarh, India Recruiting

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.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07714863

• 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

• Comparing oral itraconazole alone versus with glucocorticoids for lung disease overlap

  This study tests whether taking oral itraconazole alone or with glucocorticoids helps people with both Chronic Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis feel better.

  Recruiting Post Graduate Institute of Medical Education and Research, Chandigarh · Chandigarh, Chandigarh and 1 other locations · NCT05444946

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.