Actively Recruiting
A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2025-02-28
300
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy. In this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.
CONDITIONS
Official Title
A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with acute stage allergic bronchopulmonary aspergillosis complicating asthma according to ISHAM-ABPA criteria
- Newly diagnosed with uncontrolled asthma or symptoms or imaging showing active ABPA lesions
- Previously diagnosed with ABPA and showing sustained clinical or radiological worsening for 2 weeks or more
- Increase in serum total IgE by 50% or more from last recorded stable value
You will not qualify if you...
- Three or more ABPA exacerbations in the 18 months before enrollment
- Contraindications to prednisolone or itraconazole
- Use of oral prednisolone (or equivalent) 30 mg or more for 2 weeks or longer in the last 3 months
- Use of itraconazole, voriconazole, posaconazole, or isavuconazole for more than 2 weeks in the last 3 months
- Chronic medical illnesses such as uncontrolled diabetes, chronic kidney, liver, or heart failure
- Use of immunosuppressive drugs
- Pregnancy
- Participation in another ABPA trial
- Failure to provide informed consent
- Asthma exacerbation without immunological or radiological ABPA worsening
- Infective or bronchiectasis exacerbation without immunological or radiological ABPA worsening
- Serologic ABPA
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chest Clinic, Dept. of Pulmonary Medicine
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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