Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma: A Pilot Randomized Controlled Trial

Abstract

<b><i>Background:</i></b> Endobronchial administration of voriconazole is a potential therapeutic option for inoperable aspergilloma. <b><i>Objective:</i></b> This study aimed to assess the efficacy of endobronchial instillation of voriconazole for inoperable pulmonary aspergilloma. <b><i>Method:</i></b> Patients with mild to moderate hemoptysis, due to inoperable aspergilloma, were randomized to receive either medical therapy (MT) alone or bronchoscopic instillation of voriconazole with MT and followed up till 3 months. The primary objective of this study was to compare the percentage of patients achieving reduction in the severity of hemoptysis assessed on visual analogue scale (VAS) in intervention and control arm at 3 months. <b><i>Results:</i></b> This study included 60 patients (female = 47) with mean (SD) age of 40.6 (13.2) years who were randomized to receive either bronchoscopic instillation of voriconazole (<i>n</i> = 30) or MT alone (<i>n</i> = 30). At 3-month follow-up, the primary objective was achieved in 26/30 (86.7%) patients in intervention group as compared to 11/30 (36.7%) in the control group (<i>p</i> value &#x3c;0.0001). The VAS score at 3 months was significantly lower in voriconazole group 13.9 (9.3) mm as compared to MT alone group 22.3 (11.5) mm, <i>p</i> value of 0.003. Bronchoscopic instillation of voriconazole was also associated with reduction in cough severity and size of the aspergilloma; however, there was no benefit of this therapy in terms of requirement of hospitalization and BAE. <b><i>Conclusions:</i></b> Our study shows that for nonoperable aspergilloma, bronchoscopic instillation of voriconazole is associated with reduction in the severity of hemoptysis. This therapy should be evaluated in large multi-center trials.