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

NCT ID: NCT00266578

Last Updated: 2013-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2012-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Fluticasone Propionate

Flovent vs. placebo daily for 3 months

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marc Rothenberg

OTHER

Sponsor Role: lead

Responsible Party

Marc Rothenberg

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marc E. Rothenberg, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

FAAN

Identifier Type: -

Identifier Source: secondary_id

02-9-9

Identifier Type: -

Identifier Source: org_study_id