Last updated on November 2017

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 description of study

FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis

Detailed Study Description

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.

Clinical Study Identifier: TX133246

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Candace Cotto

Research Center
 Hamden, CT USA
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Amy Schiller

Research Center
Wyomissing, PA USA
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LaMonica Connell

Research Center
Union City, TN USA
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Diana Stockmann

Research Center
Salt Lake City, UT USA
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Catherine Barnes

Research Center
Chapel Hill, NC USA
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Robin Baker

Research Center
Greensboro, NC USA
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Natalie Saint Eloi

Research Center
Winston Salem, NC USA
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Regina Linetskaya

Research Center
San Pablo, CA USA
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Ashley Ginder

Research Center
Wyoming, MI USA
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Indiana Gonzalez

Research Center
Miami, FL USA
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Lyn Than

Research Center
Canoga Park, CA USA
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Kyle Kovtun

Research Center
Mountain View, CA USA
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Robert Windsor

Research Center
Raleigh, NC USA
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James Friend

Research Center
Rapid City, SD USA
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Maria Herrera

Research Center
San Diego, CA USA
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Nancy Moore

Research Center
El Cajon, CA USA
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Aubrie Gore

Research Center
Raleigh, NC USA
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Stephanie Stone

Research Center
North Little Rock, AR USA
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Carri Faircloth

Research Center
Mooresville, NC USA
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Matthew Burkemper

Research Center
Richardson, TX USA
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Sara Popejoy

Research Center
Rockford, IL USA
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Michael Britschge

Research Center
Salisbury, NC USA
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Chelsey Fulton

Research Center
Inverness, FL USA
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Emily Fridirici

Research Center
Camp Hill, PA USA
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Stewart Davidson

Research Center
Lake City, FL USA
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Amanda Bruggisser

Research Center
Lauderdale Lakes, FL USA
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Jessica Callis

Research Center
Hermitage, TN USA
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Blake Taylor

Research Center
Ogden, UT USA
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Amy Neeley

Research Center
Topeka, KS USA
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Tina Delarosa

Research Center
San Diego, CA USA
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Rebecca Schreiner

Research Center
Charlotte, NC USA
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Cearra Appleton

Research Center
Elkins, WV USA
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Diamond Austin

Research Center
Elkridge, MD USA
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Katrina Lauron

Research Center
Los Angeles, CA USA
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Teneshia Lewis

Research Center
Norfolk, VA USA
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Charles Wilson

Research Center
Columbus, OH USA
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Ranjit Singh

Research Center
Oak Lawn, IL USA
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Candace Cotto

Research Center
Hamden, CT USA
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