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A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
This study is ongoing, but not recruiting participants.

First Received on December 15, 2005.   Last Updated on October 24, 2008   History of Changes
Sponsor: Children's Hospital Medical Center, Cincinnati
Information provided by: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00266578
  Purpose

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


Condition Intervention Phase
Eosinophilic Esophagitis
Drug: Fluticasone Propionate
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Patients with EE treated with Flovent will demonstrate marked improvement in clinical symptoms, endoscopic findings, and histological abnormalities vs. those treated with placebo. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients demonstrating resolution of Flovent will have detectable changes in the expression of genes associated with eosinophilic infiltration by the esophageal mucosa. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2002
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fluticasone Propionate
    Flovent vs. placebo daily for 3 months
  Eligibility

Ages Eligible for Study:   3 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • 20 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266578

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Marc Rothenberg, M.D., Ph.D., Children's Hospital Medical Center - Cincinnati
ClinicalTrials.gov Identifier: NCT00266578     History of Changes
Other Study ID Numbers: 02-9-9, FAAN
Study First Received: December 15, 2005
Last Updated: October 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Eosinophilic Esophagitis

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Eosinophilia
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012