A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders

NCT00266578 | Completed Phase 3

• 2 other identifiers: 02-9-9FAAN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Histologic remission

  Histologic remission,defined by a peak eosinophil count of less than/equal to 1 eosinophil in all 400 fields in both the proximal and distal esophagus.

  5 years

Secondary Outcomes (1)

• Furrowing, Epithelial hyperplasia, clinical symptoms

  5 years

Interventions

Fluticasone Propionate DRUG

Flovent vs. placebo daily for 3 months

Eligibility Criteria

• Age: 3 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older.
• Age older than or equal to 3 years and younger than or equal to 30 years
• Endoscopic findings consistent with EE (edema, furrowing, exudates, rings)
• Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD\[11\].
• Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated.
• If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease.
• Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret Collins, MD).
• additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology.

You may not qualify if:

• Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.

Sponsors & Collaborators

• Marc Rothenberg: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marc E. Rothenberg, M.D., Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 19, 2005
• Study Start: October 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: October 1, 2012
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

US (1)