Trial reportJournal of gastroenterology and hepatology2026
Effect of Budesonide Oral Suspension on Time to First Dysphagia Symptom Response and Dysphagia Symptom Resolution Outcomes in Patients With Eosinophilic Esophagitis.
Trial report in Journal of gastroenterology and hepatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension
Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study
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Authors and funding
8 authors.
Funding
Abstract
BACKGROUND AND
aimWe examined post hoc the effect of budesonide oral suspension (BOS/Eohilia) 2.0 mg twice daily (b.i.d.) on dysphagia symptom outcomes in patients with eosinophilic esophagitis (EoE).
methodsPatients aged 11-55 years who received BOS 2.0 mg b.i.d. or placebo during phase 2 or phase 3, 12-week, double-blind, placebo-controlled clinical trials (MPI 101-06 and SHP621-301) were included. The Kaplan-Meier method captured time to first dysphagia symptom response (≥ 30% reduction in the Dysphagia Symptom Questionnaire [DSQ] score from baseline). Efficacy outcomes using the DSQ at weeks 4, 8, and 12 of therapy were: the proportion of patients with complete dysphagia symptom resolution; change from baseline in the number of dysphagia-free days; and the proportion of patients with dysphagia symptoms, but without adaptive behaviors or pain. Each outcome was measured based on daily DSQ records in the 2 weeks before each study visit.
resultsOverall, 411 patients from MPI 101-06 (BOS, n = 51; placebo, n = 42) and SHP621-301 (BOS, n = 213; placebo, n = 105) were included. Median time to first dysphagia symptom response was significantly shorter for BOS- than placebo-treated patients (MPI 101-06, p = 0.0239; SHP621-301, p = 0.0156), with separation between groups at week 2, the earliest time point measured. At all time points, higher proportions of BOS- than placebo-treated patients had complete dysphagia symptom resolution or had dysphagia symptoms but no adaptive behaviors or pain. BOS- versus placebo-treated patients also had greater improvements from baseline in the number of dysphagia-free days.
conclusionsBOS is efficacious in managing dysphagia in EoE across several symptom metrics. CLINICALTRIALS: gov: NCT01642212; NCT02605837.
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