Please select the eligibility criteria that correspond to the clinical trial below.
Title: FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis
Brief Summary: Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE.

APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.


Options:
A: Inclusion Criteria:

* Male or female between ≥18 and ≤75 years of age at the time of informed consent
* Signed informed consent
* Evidence of EoE defined by ≥15 peak eosinophils per HPF as measured from proximal and distal biopsies
* Subject-reported history of ≥3 episodes of dysphagia in the 7 days prior to Screening
* 7-day Global EoE Symptom Score \>3 at baseline and at screening
* Willing and able to adhere to study-related treatment regimens, procedures, and visit schedule

Exclusion Criteria:

* Have known contraindication, hypersensitivity, or intolerance to corticosteroids;
* Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator's judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study;
* Presence of oral or esophageal mucosal infection of any type;
* Have any mouth or dental condition that prevents normal eating;
* Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE;
* Use of systemic corticosteroids within 60 days prior to Screening, use of inhaled/swallowed corticosteroids within 30 days prior to Screening, or extended use of high-potency dermal topical corticosteroids within 30 days prior to Screening;
* Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF);
* Morning serum cortisol level ≤5 μg/dL (138 nmol/L);
* Use of biologic immunomodulators in the 24 weeks prior to Screening;
* Use of calcineurin inhibitors or purine analogues, or potent cytochrome P450 (CYP) 3A4 inhibitors in the 12 weeks prior to Screening;
* Have a contraindication to or factors that substantially increase the risk of EGD or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope;
* Have a history of an esophageal stricture requiring dilatation within the previous 12 weeks prior to Screening;
* Have initiated, discontinued or changed dosage regimen of PPIs, H2 antagonists, antacids or antihistamines for any condition such as GERD or allergic rhinitis within 4 weeks prior to qualifying endoscopy. These drugs must remain constant throughout the study.
* A serum cortisol level \<18 μg/dL (497 nmol/L) at 60 minutes with adrenocorticotropic hormone (ACTH) stimulation test using 250 μg cosyntropin (i.e., a positive result on the ACTH stimulation test).
B: Inclusion Criteria:

* Diagnosis of eosinophilic esophagitis

Exclusion Criteria:

* Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
* Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
* Evidence of pathologic eosinophilia in other locations in the GI tract.
* Participation in another research protocol
* Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)
C: Inclusion Criteria:

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

Exclusion Criteria:

* Primary causes of esophageal eosinophilia other than EoE
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: A