Clinical Trial: A Study of Flovent in Patients With Eosinophilic Esophagitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis

Brief Summary: The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone propionate (Flovent), in subjects with eosinophilic esophagitis (EE).

Detailed Summary:
Sponsor: Marc Rothenberg

Current Primary Outcome: The Percentage of Participants Who Attained Remission. [ Time Frame: 3 months ]

Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.


Original Primary Outcome: To investigate the ability of 1760mcg fluticasone propionate (FP) swallowed from a metered-dose inhaler (MDI) to induce remission of eosinophilic esophagitis (EE) (highest count of eosinophils per HPF for all esophageal biopsies to < 1 cell per HPF.

Current Secondary Outcome:

  • To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data. [ Time Frame: 3 months ]
  • To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP. [ Time Frame: 3 months ]
  • To Investigate the Relationship Between Gene Expression, Blood Levels (CBC, Serum IL-5, Eotaxin-3 and IgE) Eosinophil Phenotype, (Via Flow Cytometry and Functional Responses) and Response to FP. [ Time Frame: 3 months ]
  • To Investigate Subject Compliance and Response to FP. [ Time Frame: 3 months ]
  • To Investigate the Change in Subject Symptoms and Response to FP. [ Time Frame: 3 months ]


Original Secondary Outcome:

  • To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.
  • To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.
  • To Investigate the Relationship Between Gene Expression, Blood Levels (CBC, Serum IL-5, Eotaxin-3 and IgE) Eosinophil Phenotype, (Via Flow Cytometry and Functional Responses) and Response to FP.
  • To Investigate Subject Compliance and Response to FP.
  • To Investigate the Change in Subject Symptoms and Response to FP.


Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: January 22, 2007
Date Started: January 2007
Date Completion:
Last Updated: September 10, 2014
Last Verified: September 2014