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Benzbromarone as adjuvant therapy for cystic fibrosis lung disease: a pilot clinical trial

Benzbromarone as adjuvant therapy for cystic fibrosis lung disease: a pilot clinical trial

Frederico Friedrich1, Lucas Montiel Petry1, Laura de Castro e Garcia1, Marina Puerari Pieta1, Amanda da Silva Meneses1, Luana Braga Bittencourt1, Luiza Fernandes Xavier1, Marcos Otávio Brum Antunes1, Lucas Kich Grun1,2, Magali Lumertz1, Karl Kunzelmann3, Leonardo Araujo Pinto1

ABSTRACT

Objective: Cystic fibrosis (CF) affects multiple organs, the most severe consequences being observed in the lungs. Despite significant progress in developing CF transmembrane conductance regulator-specific treatments for CF lung disease, exploring alternative CF-targeted medications seems reasonable. We sought to evaluate the potential beneficial effects of oral benzbromarone as an adjuvant therapy in CF patients with reduced lung function. Methods: This was a prospective open-label pilot study of oral benzbromarone (100 mg/day) administered once daily for 90 days. Patients were followed at a tertiary referral center in southern Brazil. Safety was assessed by the number of reported adverse events. Secondary objectives included percent predicted FEV1 (FEV1%) and pulmonary exacerbations. Results: Ten patients were enrolled. Benzbromarone was found to be safe, with no serious drug-related adverse events. Eight patients completed the study; the median relative change in FEV1% tended to increase during the treatment, showing an 8% increase from baseline at the final visit. However, a nonparametric test showed that the change was not significant (p = 0.06). Of a total of ten patients, only one experienced at least one pulmonary exacerbation during the study. Conclusions: Oral benzbromarone appears to be safe, and improved FEV1% has been observed in patients with CF. Further assessment in larger trials is warranted to elucidate whether oral benzbromarone can be a potential adjuvant therapy for CF.

Keywords: Cystic fibrosis/therapy; Mucociliary clearance; respiratory tract diseases.

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