An open‐label non‐inferiority randomized control trial comparing nebulized amphotericin B with oral itraconazole in patients with pulmonary aspergilloma

MycosesRay A, Manikanta J, Singh K, et al. | June 22, 2021

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Researchers conducted this prospective, non-inferior, open-label, randomized control trial with the aim to determine the efficacy and safety of nebulized amphotericin B vs oral itraconazole therapy in the treatment of pulmonary aspergilloma (PA). They randomized 33 diagnosed cases of PA into the control group receiving oral itraconazole (n = 18) and intervention group receiving nebulized amphotericin B (n = 15). The control arm (oral itraconazole) vs intervention arm (nebulised amphotericin B) had overall improvement at the end of 6 months in 65% and 67% of patients, respectively, in the intention-to-treat and 79% (95% CI 49.2%–95.3%), and 65% of patients, respectively, in the per-protocol analysis. While the two arms showed no statistically significant difference in both the analyses, non-inferiority was shown in the per-protocol but not in the intention-to-treat analysis. Neither of the groups had any major adverse events; however, a significant proportion of patients receiving nAB reported minor cough (40%), which, however, did not result in discontinuation of therapy in any patients. Overall findings suggest nebulized amphotericin B as an effective treatment option for pulmonary aspergilloma patients.

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