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

Eosinophilic Esophagitis Clinical Trial

Official title:

Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266578
• Other study ID #: 02-9-9
• Secondary ID: FAAN
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2005
• Last updated: April 10, 2013
• Start date: October 2002
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Fluticasone Propionate
Flovent vs. placebo daily for 3 months

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Marc Rothenberg

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Furrowing, Epithelial hyperplasia, clinical symptoms	Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.	5 years	No