Oral Budesonide Suspension (OBS)

DRUG2 trials

Sponsors

Shire

Conditions

Eosinophilic Esophagitis (EoE)

Phase 3

A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved

CompletedNCT02605837

ShireEosinophilic Esophagitis (EoE)

Start: 2015-12-07End: 2019-02-15Updated: 2025-02-19

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)

CompletedNCT02736409

ShireEosinophilic Esophagitis (EoE)

Start: 2016-04-01End: 2019-11-12Updated: 2025-02-19

Related Papers

Effect of Budesonide Oral Suspension on Time to First Dysphagia Symptom Response and Dysphagia Symptom Resolution Outcomes in Patients With Eosinophilic Esophagitis.

2026-02-19

Effect of Esophageal Dilation History on Efficacy Outcomes in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension

UNC Libraries2025-11-13

Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis.

2024-12-232 citations

Effect of Esophageal Dilation History on Efficacy Outcomes in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension

The American Journal of Gastroenterology2024-11-123 citations

Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis

Journal of Pediatric Gastroenterology and Nutrition2023-09-183 citations

Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1–3 clinical trials

Alimentary Pharmacology & Therapeutics2023-03-0816 citations

Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis

Journal of Pediatric Gastroenterology and Nutrition2022-06-0610 citations

Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension

Clinical Gastroenterology and Hepatology2021-06-2651 citations

Budesonide Oral Suspension Improves Outcomes in Patients With Eosinophilic Esophagitis: Results From a Phase 3 Trial

Clinical Gastroenterology and Hepatology2021-04-20132 citations

A Pharmacokinetic Bridging Study to Compare Systemic Exposure to Budesonide between Budesonide Oral Suspension and ENTOCORT EC in Healthy Individuals.

2020-10-1514 citations

S0435 Determination of the Eosinophilic Esophagitis Endoscopic Reference Score Associated With Histologic Response to Therapy: Analysis From a Phase 3 Placebo-Controlled Trial of Budesonide Oral Suspension

The American Journal of Gastroenterology2020-10-015 citations

S0440 A Population Pharmacokinetic Analysis of Budesonide Oral Suspension in Children and Adults With Eosinophilic Esophagitis and Healthy Adult Volunteers

The American Journal of Gastroenterology2020-10-012 citations

S0404 Improved Histopathologic Features in Patients With Eosinophilic Esophagitis: Results and Analyses From a Phase 3, Randomized, Placebo-Controlled Trial of Budesonide Oral Suspension

The American Journal of Gastroenterology2020-10-011 citations

350 Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis in Adolescents and Adults: Results From a Phase 3, Randomized, Placebo-Controlled Trial

The American Journal of Gastroenterology2019-10-0111 citations