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Study identifier: NCT06447402 Synced from ClinicalTrials.gov · July 29, 2026
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A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis

Condition: Chronic Pulmonary Aspergillosis · CPA · Aspergilloma  ·  Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

PhasePhase 3
Planned participants196
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The treatment of CPA is with oral itraconazole for 6-12 months. Oral itraconazole results in better clinical outcomes in CPA compared to supportive care. A recent study comparing 6 months with 12 months of oral itraconazole for longer duration treatment found longer duration reduced CPA relapse and improved clinical outcomes. However, longer duration of itraconazole could cause emergence of drug resistant Aspergillus fumigatus and therapy related adverse event. A recent study found nebulized amphotericin B non-inferior to oral itraconazole for treating CPA as primary therapy. However, the study was small and included patients with simple aspergilloma and used nebulized amphotericin B for 7 days.To be effective, an inhaled drug should be delivered in sufficient quantity to achieve therapeutic levels.The minimum inhibitory concentration of amphotericin B for A.fumigatus is 0.5 mg/L. In one study, nebulization of 30 mg of amphotericin B deoxycholate achieved a mean concentration of 0.68 mg/L in the bronchoalveolar lavage fluid. Notably, the serum levels of amphotericin B after nebulization are 20 times less than after systemic administration and is safer. Further, there is a dose-response relation with nebulized amphotericin B, the higher the dose used for nebulization, the higher are the levels achieved in the lung tissue. Nebulized amphotericin B has been used in lung transplant recipients to prevent invasive aspergillosis. Also, two recent studies have demonstrated that use o…

This description comes directly from the study's public registry record.

Talk to the study team

Inderpaul S Sehgal, MD, DM  ·  91-172-2756823  ·  inderpgi@outlook.com

Always discuss trial participation with your own doctor first.

Locations (1)

Chest clinicChandigarh, IndiaRecruiting

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Source record: clinicaltrials.gov/study/NCT06447402