A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of nebulized amphotericin B, a medication delivered as a mist that patients can inhale, to see if it can help prevent relapses in patients with Chronic Pulmonary Aspergillosis (CPA). CPA is a lung infection caused by a fungus, and patients in this study have already been treated with oral antifungal medication called itraconazole for 12 months. The researchers want to find out if using nebulized amphotericin B as a maintenance therapy can keep patients stable and reduce the chances of the infection coming back.

To be eligible for the trial, participants must be adults aged 65 to 74 who have completed 12 months of oral itraconazole treatment for CPA. However, patients with certain conditions, such as those on immunosuppressive drugs or those who are pregnant, cannot participate. If you join the study, you can expect to receive nebulized amphotericin B and be monitored for its effects on your health. This trial is important because it could provide a new way to help prevent the recurrence of CPA, offering hope for better management of this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • consecutive subjects with CPA who have received 12 months therapy with oral itraconazole
• Exclusion Criteria:
• • (i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of \>10 mg prednisolone (or equivalent) for at least 3 weeks in last 3 months, or a diagnosis of human immunodeficiency virus syndrome, ; (iii) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (iv) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); (v) pregnancy.