The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

NCT00728481 | Completed Phase 2 Results DMC

• 1 other identifier: 07-006685
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD). This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort. The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux Disease; EE; GERD

Outcome Measures

Primary Outcomes (2)

• Histological Response to Treatment

  Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.

  Baseline, 6 months

• Symptomatic Response to Treatment

  Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30). Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.

  Baseline, 6 months

Secondary Outcomes (4)

• Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment

  Baseline, 6 months

• Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment

  Baseline, 6 months

• Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy

  Baseline, 6 months

• Participants With Presence of Erosive Esophagitis at Six Month Endoscopy

  Baseline, 6 months

Study Arms (2)

Esomeprazole

ACTIVE COMPARATOR

Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study (GERD)

Drug: Esomeprazole

Budesonide

ACTIVE COMPARATOR

Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)

Drug: Budesonide

Interventions

Esomeprazole DRUG

Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks

Also known as: Nexium

Esomeprazole

Budesonide DRUG

Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)

Also known as: Pulmicort

Budesonide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages 18-80.
• Patients who carry the diagnosis of Eosinophilic Esophagitis (EE) based on esophageal biopsies obtained within 18 months prior to enrollment with greater than 15 eosinophils (eos) per high power field (hpf) (400 X magnification).
• Patients who have moderate, severe, or very severe problems swallowing.

You may not qualify if:

• Patients who are currently being treated for EE.
• Patients who have used topical or systemic corticosteroid therapy for any reason over the past 4 weeks.
• Patients who have been treated with acid-suppressing medications (Proton Pump Inhibitor or H2 receptor antagonists) within 4 weeks prior to enrollment.
• Patients with known allergies or hypersensitivity to proton-pump inhibitors or corticosteroids.
• Patients who have contraindications to the procurement of biopsies including patients how have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
• Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
• Patients who have contraindications to the performance of ambulatory impedance 24-hour pH testing including patients with oropharyngeal abnormalities that would prohibit the safe passage of the transnasal catheter and patients who are currently using warfarin, have a history of bleeding disorders or bleeding diatheses.
• Patients who are pregnant.

Sponsors & Collaborators

• Mayo Clinic: lead
• AstraZeneca: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Francis DL, Foxx-Orenstein A, Arora AS, Smyrk TC, Jensen K, Nord SL, Alexander JA, Romero Y, Katzka DA. Results of ambulatory pH monitoring do not reliably predict response to therapy in patients with eosinophilic oesophagitis. Aliment Pharmacol Ther. 2012 Jan;35(2):300-7. doi: 10.1111/j.1365-2036.2011.04922.x. Epub 2011 Nov 24.

  PMID: 22111863 RESULT

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux

Interventions

Esomeprazole; Budesonide

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; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The index endoscopy was obtained solely for clinical reasons and could have been done as long as 18 months prior to study enrollment. A single question on the dysphagia questionnaire was used to assess dysphagia symptom response.

Results Point of Contact

• Title: Dr. Amy Foxx-Orenstein, D.O., Associate Prof. of Medicine, College of Medicine
• Organization: Mayo Clinic

foxx-orenstein.amy@mayo.edu

480-301-8806

Study Officials

• Amy Foxx-Orenstein, D.O.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: August 5, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 14, 2016
• Results First Posted: December 6, 2012

Record last verified: 2016-01

Locations

US (1)