Status:
RECRUITING
A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Allergic Bronchopulmonary Aspergillosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergil...
Detailed Description
The principles of treating ABPA include using glucocorticoids to control the immunologic activity and antifungal agents to attenuate the fungal burden in the airways.4 Glucocorticoids are the first li...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06174922
Start Date
December 1 2023
End Date
June 1 2026
Last Update
February 28 2025
Active Locations (1)
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1
Chest Clinic, Dept. of Pulmonary Medicine
Chandigarh, Chandigarh, India, 160012