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00925njm 22002777a 4500 dc Fortún, Jesús author Gómez-García de la Pedrosa, Elia author Martínez-Lorca, Alberto author Paredes, Patricia author Martín-Dávila, Pilar author Gomez-Lopez, Alicia author Buitrago, Maria Jose author López-Jiménez, Javier author Gioia, Francesca author Escudero, Rosa author Alvarez-Alvarez, Maria Elena author Soriano, Cruz author Moreno-García, Javier author San Miguel, Diana author Vicente, Noelia author Moreno, Santiago author 2024-03-01 Although nebulized liposomal amphotericin B (NLAB) is being used in invasive pulmonary aspergillosis (IPA) prophylaxis, no clinical trial has shown its efficacy as a therapeutic strategy. NAIFI is the inaugural randomized, controlled clinical trial designed to examine the safety and effectiveness of NLAB (dosage: 25 mg in 6 mL, three times per week for 6 weeks) against a placebo, in the auxiliary treatment of IPA. Throughout the three-year clinical trial, thirteen patients (six NLAB, seven placebo) were included, with 61% being onco-hematological with less than 100 neutrophils/μL. There were no significant differences noted in their pre- and post-nebulization results of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and oxygen saturation between the groups. Neither bronchospasm nor serum amphotericin B levels were reported in any patients given NLAB. 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET-TC) was carried out at the baseline and after 6 weeks. A notable decrease in median SUV (standardized uptake value) was observed in NLAB patients after 6 weeks (-3.6 vs. -0.95, p: 0.039, one tail). Furthermore, a reduction in serum substance galactomannan and beta-D-Glucan was identified within NLAB recipients. NLAB is well tolerated and safe for patients with IPA. Encouraging indirect efficacy data have been derived from image monitoring or biomarkers. However, further studies involving more patients are necessary. Fortún J, Gómez-García de la Pedrosa E, Martínez-Lorca A, Paredes P, Martín-Dávila P, Gómez-López A, Buitrago MJ, López-Jiménez J, Gioia F, Escudero R, Alvarez-Alvarez ME, Soriano C, Moreno-García J, San Miguel D, Vicente N, Moreno S. A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis. J Fungi (Basel). 2024 Mar 1;10(3):191. 10.3390/jof10030191 2309-608X Journal of fungi (Basel, Switzerland) 38535200 https://hdl.handle.net/20.500.12105/26574 18F-fluorodeoxyglucose positron emission tomography Invasive pulmonary aspergillosis Nebulized liposomal amphotericin B A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis