Topical Steroid Treatment for Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275561
First received: January 10, 2006
Last updated: May 1, 2012
Last verified: May 2012

January 10, 2006
May 1, 2012
November 2005
April 2010   (final data collection date for primary outcome measure)
Number of Participants With Complete Response to Dysphagia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"
  • Dysphagia by questionaire
  • Side effects by questionaire
Complete list of historical versions of study NCT00275561 on ClinicalTrials.gov Archive Site
  • Number of Participants With Partial or Complete Response to Dysphagia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?" A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level.
  • Number of Participants With Complete Histologic Response [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field
Eosinophil degranulation
Not Provided
Not Provided
 
Topical Steroid Treatment for Eosinophilic Esophagitis
A Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic Esophagitis

This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food.

Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.

This was a double-blind randomized placebo controlled trial to evaluate the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults newly diagnosed with eosinophilic esophagitis (EoE). Participants were randomized to receive aerosolized swallowed fluticasone 880 mcg bid or placebo inhaler swallowed bid for 6 weeks.

Four mid esophageal biopsies were obtained from 10 cm above the squamo-columnar junction; then formalin-fixed and stained with hematoxylin and eosin. All esophageal biopsies were read and scored by a single expert gastrointestinal pathologist. The formalin-fixed paraffin-embedded esophageal biopsies were retrieved and underwent standard major basic protein (MBP) immunofluorescence staining. All special stain slides were then read and scored by another pathologist. 24-hour urine was collected for free cortisol by the standard technique. The original endoscopy was performed before the patient was enrolled in the trial by standard clinical technique. The endoscopy post treatment was done in the clinical research unit by the principal investigator.

Patients kept compliance logs that were reviewed at phone interviews at 2 and 4 weeks time and at the end of study evaluation. Ninety percent compliance was required for study inclusion.

At the end of 6 weeks, a 24-hour urine cortisol was done, and patients underwent a repeat endoscopy while still on treatment. Mid-esophageal biopsies were obtained and evaluated for eosinophil density and mast cell degranulation. At this visit the patients returned dysphagia and side effects questionnaires.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Eosinophilic Esophagitis
  • Drug: Fluticasone
    Aerosolized swallowed fluticasone 880 mg twice a day
    Other Names:
    • Flonase
    • Veramyst
  • Drug: Placebo
    Placebo inhaler swallowed twice a day for 6 weeks
  • Experimental: Fluticasone
    Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
    Intervention: Drug: Fluticasone
  • Placebo Comparator: Placebo
    Placebo inhaler swallowed bid for 6 weeks
    Intervention: Drug: Placebo
McElhiney J, Lohse MR, Arora AS, Peloquin JM, Geno DM, Kuntz MM, Enders FB, Fredericksen M, Abdalla AA, Khan Y, Talley NJ, Diehl NN, Beebe TJ, Harris AM, Farrugia G, Graner DE, Murray JA, Locke GR 3rd, Grothe RM, Crowell MD, Francis DL, Grudell AM, Dabade T, Ramirez A, Alkhatib M, Alexander JA, Kimber J, Prasad G, Zinsmeister AR, Romero Y. The Mayo Dysphagia Questionnaire-30: documentation of reliability and validity of a tool for interventional trials in adults with esophageal disease. Dysphagia. 2010 Sep;25(3):221-30. Epub 2009 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • > 20 eosinophils / hpf on biopsies from mid esophagus (hpf = high-powered field)
  • Abnormal dysphagia questionnaire (question 1a "yes", question 1c > "moderate" and question 2 > "less than once a week") on Mayo Dysphagia Questionnaire.

Exclusion Criteria:

  • Clinical evidence of infectious process potentially contributing to dysphagia (e.g., candidiasis, cytomegalovirus, herpes)
  • Systemic or topical steroid therapy for any reason over the past 3 months
  • Previous steroid treatment for Eosinophilic Esophagitis
  • Intolerance to steroid therapy in the past
  • Other cause of dysphagia identified at endoscopy (e.g., reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
  • Dilatation of esophagus at time of index endoscopy
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275561
1488-05
No
Jeffrey A. Alexander, M.D, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Jeffrey A. Alexander, M.D. Mayo Clinic
Mayo Clinic
May 2012

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