Please select the eligibility criteria that correspond to the clinical trial below.
Title: Oral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and Adolescents
Brief Summary: This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.


Options:
A: Inclusion Criteria:

* Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
* Ages 1 yrs and older
* Ability to continue the same diet that the patient was on at the time of EGD with biopsy

Exclusion Criteria:

* Adverse reaction or allergy to budesonide
* Pregnancy
* Chronic diseases requiring immunomodulatory therapy
* Use of swallowed topical corticosteroids for EE within the past 3 months
* Use of systemic steroids 2 months prior to study entry
* Upper gastrointestinal bleed within 4 months of study entry
* Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
* Evidence of adrenal suppression prior to study entry
* Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
* Recent changes in asthma or allergic rhinitis therapy for 3 months
B: 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
C: Inclusion criteria are as follows:

* Age: 16 - 80 years
* Subject is having a clinically indicated endoscopy for suspicious EoE and has been on twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of EoE as per consensus guidelines. Cases must have symptoms of dysphagia, persistent esophageal eosinophilia (≥ 15 eosinophils in at least one high-power field) after 8 weeks of treatment with a twice daily proton-pump inhibitor, and other competing causes of esophageal eosinophilia excluded.

Exclusion criteria are as follows:

* Medical instability that precludes safely performing upper endoscopy
* Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in the stool)
* Concomitant eosinophilic gastroenteritis
* Esophageal narrowing or stricturing that will not allow a standard 9 mm upper endoscopy scope to pass
* Cancer in the esophagus, stomach, or intestine
* Previous esophageal surgery
* Esophageal varices (dilated blood vessels in the esophagus)
* Current use of blood thinners like Plavix or Coumadin that are not stopped prior to endoscopy procedures
* Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic exam. Exclusionary corticosteroid exposure is defined as any swallowed topical steroids for EoE or systemic steroids for any condition within the four weeks prior to the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids are not an exclusion and are allowable.
* Pregnancy
* Inability to read or understand English
D: Inclusion Criteria:

* Male and female subjects between the ages of 2-18 years, inclusive
* History of clinical symptoms of esophageal dysfunction intermittently or continuously
* Histologic evidence of EoE with a peak eosinophil count of greater than or equal to 20 eosinophils per HPF, from two or more levels of the esophagus, within six weeks prior to the Baseline Visit
* At the Baseline Visit, subjects must have symptoms with a total EoE Clinical Symptom Score of greater than or equal to 3
* Willingness and ability to continue the dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression, if any) in effect at the Screening Visit
* Females of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) prior to randomization into the study and sexually active subjects must agree to continue acceptable birth control measures throughout the duration of the study
* Written informed consent (parent or legal guardian) and, as appropriate, subject assent

Exclusion Criteria:

* Current use of immunomodulatory therapy (or anticipated use within 12 weeks following the Baseline Visit)
* Diagnosis of inflammatory bowel disease
* Chronic viral infection or immunodeficiency condition (current)
* Use of swallowed topical corticosteroids for EoE in the 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
* Use of systemic (oral or parenteral) corticosteroid within 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
* Morning plasma cortisol level below the lower limit of normal (per Central Laboratory reference range) at the Screening Visit
* Upper gastrointestinal bleeding within 1 month prior to the Screening Visit or between the Screening Visit and Baseline Visit
* Current use of anticoagulants
* Current disease of the gastrointestinal tract aside from the current EoE diagnosis
* Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
* Evidence of active infection with Helicobacter pylori
* Evidence of unstable asthma or changes in asthma or allergic rhinitis therapy within 1 month prior to the biopsy required for entrance to this study
* Any female who is pregnant, who is planning to become pregnant, or who is breast-feeding
* Current evidence or history of hypersensitivity or idiosyncratic reaction to budesonide or any other ingredients of the study medication
* Current evidence of oropharyngeal or esophageal candidiasis
* Receipt of an investigational drug within 30 days prior to the biopsy required for entrance to this study
* Any condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the subject or successful conduct of the study

Answer: D