Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fouad J. Moawad, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00895817
First received: May 6, 2009
Last updated: March 11, 2013
Last verified: March 2013

May 6, 2009
March 11, 2013
April 2008
October 2010   (final data collection date for primary outcome measure)
Number of Participants Who Responded [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.
Histologic resolution of esophageal eosinophilia defined as < 7 eosinophils/high power field in both the proximal and distal esophagus. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00895817 on ClinicalTrials.gov Archive Site
  • Symptom Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.
  • Endoscopic Change [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Following therapy, resolution of EE findings will be assessed.
  • Resolution of dysphagia symptoms with therapy using a validated questionnaire. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Endoscopic resolution of EE findings following treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis

The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.

The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Eosinophilic Esophagitis
  • Drug: Swallowed fluticasone
    440 µg twice daily for 8 weeks
  • Drug: Esomeprazole
    40 mg once daily for 8 weeks
  • Active Comparator: Swallowed fluticasone
    Intervention: Drug: Swallowed fluticasone
  • Active Comparator: Esomeprazole
    Intervention: Drug: Esomeprazole
Not Provided

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

Inclusion Criteria:

  • Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
  • Males and females age > 18 years of age.
  • Ability to undergo ambulatory pH monitoring.
  • DEERS (Defense Enrollment Eligibility Reporting System) eligible.
  • Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
  • Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.

Exclusion Criteria:

  • Patients < 18 years of age.
  • Inability to give consent.
  • Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
  • Contraindications to proton pump inhibitors or steroids.
  • Inability to accurately fill out a short questionnaire.
  • Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
  • Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00895817
08-14045
Yes
Fouad J. Moawad, Walter Reed Army Medical Center
Walter Reed Army Medical Center
Not Provided
Principal Investigator: Fouad J Moawad, M.D. Walter Reed Army Medical Center
Walter Reed Army Medical Center
March 2013

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