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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00266578
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Fluticasone Propionate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial
Study Start Date : October 2002
Actual Primary Completion Date : November 2006
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Fluticasone Propionate
    Flovent vs. placebo daily for 3 months

Outcome Measures
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Primary Outcome Measures :
  1. Histologic remission [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. Furrowing, Epithelial hyperplasia, clinical symptoms [ Time Frame: 5 years ]
    Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266578


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Marc Rothenberg
Investigators
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Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Marc Rothenberg, MD, PhD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00266578    
Other Study ID Numbers: 02-9-9
FAAN
First Posted: December 19, 2005    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Marc Rothenberg, Children's Hospital Medical Center, Cincinnati:
Eosinophilic Esophagitis
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Fluticasone
Xhance
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents