Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

Dr. Falk Pharma

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: high dose budesonide tablet; Drug: high dose budesonide suspension; Drug: low dose budesonide tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280616

2009-016692-29 (EudraCT Number)

BUU-2/EEA

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• Signed informed consent
• Male or female patients, 18 to 75 years of age
• Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria:

(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)

• Active symptomatic and histological EoE at baseline

Major Exclusion Criteria:

• Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia
• Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia
• Other clinical evident causes than EoE for esophageal eosinophilia
• Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection)
• Any relevant systemic disease (e.g., AIDS, active tuberculosis)
• Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension
• Abnormal renal function at screening
• History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)
• History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit
• Upper gastrointestinal bleeding within 8 weeks prior to screening visit
• Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants
• Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate
• Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment
• Intake of grapefruit containing food or beverages during the treatment with study medication
• Known intolerance/hypersensitivity to study drug
• Existing or intended pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

76 participants in 4 patient groups, including a placebo group

Low dose budesonide tablet

Experimental group

Treatment:

Drug: low dose budesonide tablet

High dose budesonide tablet

Experimental group

Treatment:

Drug: high dose budesonide tablet

High dose budesonide suspension

Experimental group

Treatment:

Drug: high dose budesonide suspension

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo