Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123656
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : January 16, 2008
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by:
University of Utah

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 25, 2005
Last Update Posted Date January 16, 2008
Study Start Date  ICMJE August 2004
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2007)
To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2007)
To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using valudated questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Official Title  ICMJE Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Brief Summary Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
Detailed Description

This is a randomized, non-blinded, multicenter treatment trial to demonstrate and compare the efficacy of esomeprazole and fluticasone in the treatment of eosinophilic esophagitis.

Following the initial diagnostic EGD with four quadrant biopsy, serum eosinophil count and serum IgE levels will be measured. Patients will undergo 24 hour pH study to determine the incidence of reflux in this population. Clinical assessment will be performed with validated questionnaires quantifying dysphagia, GERD, and allergy/atopy. Patients will be randomized to 8 weeks of either esomeprazole versus swallowed aerosolized fluticasone. After 8 weeks of therapy, upper endoscopy will again be performed. Eosinophils per high power field will be quantified, and biopsies will be stained for major basic protein. Dysphagia, GERD, and allergy/atopy questionnaires will be repeated, as will serum eosinophil counts and IgE measurements.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophagitis
Intervention  ICMJE
  • Drug: esomeprazole
    esomeprazole dosed qam for 8 weeks
    Other Name: Nexium
  • Drug: fluticasone
    fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
    Other Name: Flovent
Study Arms  ICMJE
  • Active Comparator: 1
    fluticasone
    Intervention: Drug: fluticasone
  • Active Comparator: 2
    esomeprazole
    Intervention: Drug: esomeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18-80 with EE, defined as: a) dysphagia, food impaction or other upper gastrointestinal symptoms (chest pain, heartburn, regurgitation); b) multiple esophageal rings or furrows; c) the presence of >20 eosinophils/high power field in the squamous epithelium or deeper tissues of the esophagus
  • Ability to undergo esophageal manometry and ambulatory pH monitoring
  • No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy
  • Those who have had a one month holiday from either esomeprazole therapy or fluticasone if they have been prescribed this prior to enrollment

Exclusion Criteria:

  • Contraindication to proton pump inhibitors or swallowed fluticasone
  • Need for immediate esophageal dilation at enrollment due to food impaction at the discretion of the performing endoscopist
  • Inability to pass endoscope
  • Pregnancy
  • Incarceration
  • Inability to provide informed consent
  • History of esophago-gastric surgery or prior history of abdominal surgery with subsequent strictures or symptoms of obstruction such as abdominal pain and bloating
  • Presence of other esophageal pathology that could account for patients' symptoms as determined by histological interpretation by the pathologist
  • History of esophageal spasm resulting in trouble swallowing foods larger than 1 cm in diameter
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123656
Other Study ID Numbers  ICMJE 12790
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John C. Fang, M.D., University of Utah HSC
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE American Society for Gastrointestinal Endoscopy
Investigators  ICMJE
Principal Investigator: John C. Fang, M.D. University of Utah HSC
PRS Account University of Utah
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP