Please select the eligibility criteria that correspond to the clinical trial below.
Title: Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
Brief Summary: Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response.

Participants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized.

Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims


Options:
A: Inclusion Criteria:

* Histologic evidence of EoE
* Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

* Primary causes of esophageal eosinophilia other than EoE
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:

* Age over 18 years
* Newly diagnosed cases with diagnostic criteria for EoE (ie at least 15 eosinophils per high power field (Magnification 10 times 40 = x400) in any field of view in any esophageal biopsy and concurrent symptoms of esophageal dysfunction mainly dysphagia.
* Women of childbearing age may participate provided that the pregnancy is not planned , and that contraceptive use during therapy. The investigator will arrange a free pregnancy test must be performed within 1 week before treatment and be negative.
* Participation requires oral and written informed and signed consent form (see patient information and consent forms).

Exclusion Criteria:

* Local infection of the pharynx or esophagus , such as fungal, bacterial or viral infection
* Active or latent tuberculosis in respiratory tract
* Recent history of major trauma or major surgery
* Recent significant infection or other physical stress
* Signs or suspicion of dehydration
* History of injury, illness or surgery in the adrenals or pituitary
* Pharynx or esophagussurgery or other trauma in the esophagus (incl. foreign body with a sharp object ) where healing has not taken place. (in case of doubt to be assessed by esophago - gastroscopy.
* Planned elective surgery during treatment
* Pregnancy, ongoing or planned
* Women of childbearing potential not using preventives during the study period
* Glaucoma
* Hypersensitivity to any component in the treatments
* Systemic or local steroid treatment last 4 months
* Contraindication to steroid therapy ( immune deficiency or suppression , stomach ulcers, diabetes)
* Medications that affect oesophageal motility (cisapride, erythromycin ) during the treatment period .
* PPIs during or up to 2 weeks before the treatment period
* Other cause of dysphagia (cancer, connective tissue disease , neurological disease )
* Volunteer who can not consent to the study or complete a questionnaire

Answer: C