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A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
This study is ongoing, but not recruiting participants.
Study NCT00266578   Information provided by Children's Hospital Medical Center, Cincinnati
First Received: December 15, 2005   Last Updated: October 24, 2008   History of Changes

December 15, 2005
October 24, 2008
October 2002
April 2012   (final data collection date for primary outcome measure)
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 ]
Patients with EE treated with Flovent will demonstrate marked improvement in clinical symptoms, endoscopic findings, and histological abnormalities vs. those treated with placebo. The effect may be more pronounced in non-allergic patients.
Complete list of historical versions of study NCT00266578 on ClinicalTrials.gov Archive Site
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 ]
Patients demonstrating resolution of Flovent will have detectable changes in the expression of genes associated with eosinophilic infiltration by the esophageal mucosa.
 
A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial

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

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Eosinophilic Esophagitis
Drug: Fluticasone Propionate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
3 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00266578
Marc Rothenberg, M.D., Ph.D., Children's Hospital Medical Center - Cincinnati
02-9-9, FAAN
Children's Hospital Medical Center, Cincinnati
 
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
October 2008

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