Topical Steroid Treatment for Eosinophilic Esophagitis

NCT00275561 | Completed Phase 2 Results

• 1 other identifier: 1488-05
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; Fluticasone; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response to Dysphagia

  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)?"

  2 weeks

Secondary Outcomes (2)

• Number of Participants With Partial or Complete Response to Dysphagia

  2 weeks

• Number of Participants With Complete Histologic Response

  2 weeks

Study Arms (2)

Fluticasone

EXPERIMENTAL

Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks

Drug: Fluticasone

Placebo

PLACEBO COMPARATOR

Placebo inhaler swallowed bid for 6 weeks

Drug: Placebo

Interventions

Fluticasone DRUG

Aerosolized swallowed fluticasone 880 mg twice a day

Also known as: Flonase, Veramyst

Fluticasone

Placebo DRUG

Placebo inhaler swallowed twice a day for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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. doi: 10.1007/s00455-009-9246-8. Epub 2009 Oct 24.

  PMID: 19856027 BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis; Deglutition Disorders

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The relatively small sample size; unexpected high dropout rate in the placebo group; study commenced before the consensus definition of EoE advising exclusion of gastroesophageal reflux disease (GERD) was established.

Results Point of Contact

• Title: Jeffrey A. Alexander, MD, Assistant Professor of Medicine
• Organization: Mayo Clinic

alexander.jeffrey14@mayo.edu

507-538-2403

Study Officials

• Jeffrey A. Alexander, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 12, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 8, 2012
• Results First Posted: December 8, 2011

Record last verified: 2012-05

Locations

US (1)