Actively Recruiting
A Randomized Controlled Trial Comparing Oral Itraconazole Alone Versus Combined Systemic Glucocorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2026-04-07
104
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the overlap syndrome of allergic bronchopulmonary aspergillosis (ABPA) and chronic pulmonary aspergillosis (CPA), two distinct lung diseases caused by Aspergillus infection that sometimes occur together. This trial aims to compare the clinical outcomes of patients with ABPA-CPA overlap treated with either oral itraconazole alone or a combination of systemic glucocorticoids and oral itraconazole. The study explores whether combining treatments may better address the complex immune responses in this overlap condition. The study involves two treatment groups. One group receives oral itraconazole (400 mg/day) for 12 months, with dose adjustments based on blood levels. The other group receives a combination of oral prednisolone (0.5 mg/kg body weight) tapered over 4 months plus oral itraconazole for 12 months. The goal is to evaluate how these treatments affect the patient's condition over time and to assess the safety and relapse rates. Participants will be monitored through clinical evaluations, imaging studies, and laboratory testing including immunological markers like total IgE and Aspergillus-specific antibodies. Outcomes such as favorable response at 6 months, overall response at 12 months, relapse frequency at 18 months, and adverse events will be recorded. The study includes ongoing assessments of serum IgE during treatment and relapse, with a total participation period extending up to 18 months after randomization.
CONDITIONS
Brief Title
Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 15 and 90 years
- Diagnosed with both allergic bronchopulmonary aspergillosis (ABPA) and chronic pulmonary aspergillosis (CPA)
- For CPA: symptoms lasting 3 months or more, specific CT chest findings, immunological or microbiological evidence of Aspergillus infection, and exclusion of other similar lung disorders
- For ABPA: elevated A.fumigatus specific IgE (>0.35 kUA/L), total IgE ≥500 IU/mL, eosinophil count ≥500 cells/µL, and A.fumigatus IgG >27 mgA/L
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Taking immunosuppressive drugs or prednisolone equivalent >10 mg daily for at least 3 weeks
- Use of antifungal triazoles for more than 3 weeks in the past 3 months
- Active pulmonary infections due to tuberculosis or non-tuberculous mycobacteria
- Other forms of pulmonary aspergillosis (subacute or acute invasive)
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 12 months
Participants receive oral itraconazole alone or combined with systemic glucocorticoids for managing CPA-ABPA overlap syndrome.
Regular visits for medication adjustment and monitoring during treatment
Duration - 6 months after treatment completion
Participants are monitored for treatment response, relapse frequency, and adverse events after treatment ends.
Visits at 6, 12, and 18 months after randomization for assessment
Trial Site Locations
Total: 2 locations
1
Chest clinic
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
2
Chest clinic, PGIMER
Chandigarh, India, 160012
Active, Not Recruiting
Research Team
I
Inderpaul S Sehgal, MD, DM
R
Ritesh Agarwal, MD,DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here