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Clinical Trial
. 2023 Aug 1;77(2):249-255.
doi: 10.1097/MPG.0000000000003830. Epub 2023 May 17.

Oral Viscous Budesonide in Children With Eosinophilic Esophagitis After Repaired Esophageal Atresia: A Clinical Trial

Renato Tambucci  1 , Marco Roversi  2 , Francesca Rea  1 , Monica Malamisura  1 , Giulia Angelino  1 , Isabella Biondi  3 , Raffaele Simeoli  4 , Bianca Maria Goffredo  4 , Paola Francalanci  1 , Alessandra Simonetti  3 , Susanna Livadiotti  3 , Tiziana Corsetti  5 , Luigi Dall'Oglio  6 , Paolo Rossi  3 , Giuseppe Pontrelli  3 , Paola De Angelis  1
Affiliations
Clinical Trial

Oral Viscous Budesonide in Children With Eosinophilic Esophagitis After Repaired Esophageal Atresia: A Clinical Trial

Renato Tambucci et al. J Pediatr Gastroenterol Nutr. .

Abstract

Objectives: A high prevalence of eosinophilic esophagitis (EoE) has been reported in children with repaired esophageal atresia (EA). Topical steroids proved to be an effective and safe therapy in EoE, although not approved in pediatrics. We report the results of the first clinical trial of oral viscous budesonide (OVB) performed in children with EoE after repaired esophageal atresia (EoE-EA).

Methods: This open-label, single-arm, phase 2 clinical trial with randomized pharmacokinetic sampling, was conducted at the Bambino Gesù Children's Hospital between September 2019 and June 2021. EoE-EA patients received an age-banded dose of OVB twice daily for 12 weeks and were endoscopically evaluated. The primary endpoint was the rate of patients achieving histological remission. Secondary endpoints included clinical and endoscopic benefit after treatment, and safety assessments.

Results: Eight consecutive EA-EoE patients were enrolled (median age 9.1 years, interquartile range 5.5). Of these, 5 received 0.8 mg and 3 received 1.0 mg twice daily of OVB. Histological remission was obtained in all but 1 patient (87.5%). The clinical score showed significant improvement at the end of treatment in all patients. No endoscopic features of EoE were found after treatment. No treatment-emergent adverse event occurred.

Conclusion: OVB is an effective, safe, and well-tolerated formulation of budesonide for use in pediatric patients with EoE-EA.

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Conflict of interest statement

The authors report no conflicts of interest.

References

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