Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients

Exclusion Criteria

• •1. Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test.
• •2. Nursing mothers.
• •3. Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin.
• •4. Subjects with a past history of bronchospasm associated with aerosol drug use.
• •5. Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications.
• •6. Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month.
• •7. Subjects with an FEV1\< 30% Predicted or FVC% \<30%.
• •8. Subjects requiring supplemental oxygen.
• •9. Receipt of Inhaled or IV Amphotericin B within last 30 days.
• •10. Subjects with known fungal infection as per MSG Criteria on therapy with antifungal drugs or diagnosed on the day of bronchoscopy.
• •11. Current use of azoles active against molds (Voriconazole, itraconazole, posaconazole) for the prophylaxis.
• •12. Serum creatinine \> 150 mmol/L on the day of clinic visit.
• •13. Liver enzymes ALT/ AST/ Alkphos greater than two times upper limit of normal.
• •14. Concurrent intravenous aminoglycoside use.
• •15. Subjects with fever \> 38.2°C.
• •16. Subjects on mechanical ventilation.
• •17. Expected survival less than 6 months.
• •18. Re-transplants and heart/lung transplant patients.