Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis
Copyright policy )Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis
ABSTRACTBackgroundEsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO‐101) is under investigation for the treatment of eosinophilic oesophagitis (EoE).AimsTo evaluate the efficacy, safety and tolerability of ESO‐101 in patients with active EoE.MethodsWe conducted a randomised, placebo‐controlled, phase 2, proof‐of‐concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (n = 15), or EsoCap loaded with 800 μg of mometasone furoate (n = 28) once daily during 28 days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures.ResultsTreatment with ESO‐101 resulted in reduction (mean ± SD) of 49.1 ± 88.4 eosinophils/high‐power field from baseline, compared with 6.6 ± 65.1 with placebo (p = 0.03). With ESO‐101, 48% and 44% of patients achieved < 15 and < 6 eosinophils/high‐power field, respectively; these were 0% with placebo. EoE Endoscopic Reference Score reduced significantly in patients treated with ESO‐101. In contrast, dysphagia and odynophagia severity decreased similarly in both groups. There were no serious treatment‐emergent adverse events. Mean serum cortisol did not change significantly throughout the trial. Notably, no oropharyngeal or oesophageal candidiasis was documented. The device was well tolerated.ConclusionsESO‐101 was superior to placebo in reducing oesophageal eosinophilia. The device was safe and well tolerated in adults with EoE, supporting the continued development of ESO‐101 for the treatment of EoE (Trials.gov No.: NCT04849390; Eu‐CT No.: 2020–000082‐16).
- Amsterdam UMC Netherlands
- University of North Carolina at Chapel Hill United States
- Amsterdam University Medical Centers Netherlands
- University of North Carolina System United States
- Servicio de Salud de Castilla La Mancha Spain
Male, Adult, corticosteroid, Other subheadings::Other subheadings::/therapeutic use, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Administration, Topical, Otros calificadores::Otros calificadores::/uso terapéutico, Corticosteroides - Ús terapèutic, 610 Medicine & health, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Administration Routes::Administration, Topical, Young Adult, Drug Delivery Systems, Esophagus, Double-Blind Method, CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones, Adrenal Cortex Hormones, 2736 Pharmacology (medical), Humans, 2715 Gastroenterology, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Delivery Systems, Eosinofília, Aged, eosinophilic oesophagitis, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::sistemas de liberación de medicamentos, Other subheadings::Other subheadings::Other subheadings::/drug therapy, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome, Medicaments - Modes d'administració, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::vías de administración de medicamentos::administración tópica, Eosinophilic Esophagitis, Middle Aged, Clinical Trial, 10219 Clinic for Gastroenterology and Hepatology, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento, Treatment Outcome, COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas de la corteza suprarrenal, topical therapy, DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Esophageal Diseases::Esophagitis::Eosinophilic Esophagitis, drug delivery, histopathology, Avaluació de resultats (Assistència sanitària), 2721 Hepatology, Esòfag - Malalties - Tractament, ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::enfermedades del esófago::esofagitis::esofagitis eosinofílica, Female, Mometasone Furoate
Male, Adult, corticosteroid, Other subheadings::Other subheadings::/therapeutic use, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Administration, Topical, Otros calificadores::Otros calificadores::/uso terapéutico, Corticosteroides - Ús terapèutic, 610 Medicine & health, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Administration Routes::Administration, Topical, Young Adult, Drug Delivery Systems, Esophagus, Double-Blind Method, CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones, Adrenal Cortex Hormones, 2736 Pharmacology (medical), Humans, 2715 Gastroenterology, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Delivery Systems, Eosinofília, Aged, eosinophilic oesophagitis, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::sistemas de liberación de medicamentos, Other subheadings::Other subheadings::Other subheadings::/drug therapy, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome, Medicaments - Modes d'administració, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::vías de administración de medicamentos::administración tópica, Eosinophilic Esophagitis, Middle Aged, Clinical Trial, 10219 Clinic for Gastroenterology and Hepatology, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento, Treatment Outcome, COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas de la corteza suprarrenal, topical therapy, DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Esophageal Diseases::Esophagitis::Eosinophilic Esophagitis, drug delivery, histopathology, Avaluació de resultats (Assistència sanitària), 2721 Hepatology, Esòfag - Malalties - Tractament, ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::enfermedades del esófago::esofagitis::esofagitis eosinofílica, Female, Mometasone Furoate
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