Actively Recruiting
A Randomized Controlled Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Increasing Time to Relapse in Patients With Chronic Pulmonary Aspergillosis Treated With 12 Months of Oral Itraconazole
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2024-06-10
196
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic Pulmonary Aspergillosis (CPA) is a serious lung disease caused by the fungus Aspergillus, primarily affecting people with damaged lungs such as those recovering from tuberculosis. CPA has a high mortality rate and is often misdiagnosed as tuberculosis, leading to delays in proper antifungal treatment. This trial aims to evaluate the use of nebulized amphotericin B as maintenance therapy to reduce relapse and prolong time to relapse in CPA patients who have completed 12 months of oral itraconazole treatment. Participants will be randomly assigned to receive either nebulized amphotericin B deoxycholate twice daily or nebulized normal saline as a placebo. The amphotericin B is prepared by mixing a specific dose with distilled water to ensure full nebulization. The study compares these two inhalation treatments to see which better maintains health after initial oral antifungal therapy, with treatments continuing as maintenance following 12 months of oral itraconazole. Throughout the 12 months following randomization, participants will be closely monitored for time to first exacerbation, frequency of relapses, and any treatment-related side effects. Assessments include clinical evaluations and safety monitoring to determine the effects of the nebulized treatments as maintenance therapy. This trial will help understand the potential benefits and safety of inhaled amphotericin B in managing CPA over a year-long period.
CONDITIONS
Brief Title
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consecutive subjects with chronic pulmonary aspergillosis who have completed 12 months of oral itraconazole therapy
You will not qualify if you...
- Failure to provide informed consent
- Use of immunosuppressive drugs or intake of more than 10 mg prednisolone (or equivalent) daily for at least 3 weeks in the last 3 months
- Diagnosis of human immunodeficiency virus syndrome
- Active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis
- Other forms of pulmonary aspergillosis such as subacute or acute invasive aspergillosis
- 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.
1 visit (in-person)
Duration - 12 months after randomization
Participants receive nebulized amphotericin B or nebulized normal saline as maintenance therapy following completion of 12 months of oral itraconazole therapy for chronic pulmonary aspergillosis.
Twice daily nebulization throughout treatment; visit schedule as per trial protocol
Duration - Up to 12 months after randomization
Participants are monitored for time to first exacerbation, frequency of relapses, and treatment emergent adverse events after the maintenance therapy period.
Visits as scheduled to monitor clinical outcomes and adverse events
Trial Site Locations
Total: 1 location
1
Chest clinic
Chandigarh, India, 160012
Actively Recruiting
Research Team
I
Inderpaul S Sehgal, MD, DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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