A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
This study has been completed.
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
First received: December 15, 2005
Last updated: April 10, 2013
Last verified: April 2013
The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
|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:
U.S. FDA Resources
Further study details as provided by Children's Hospital Medical Center, Cincinnati:
Primary Outcome Measures:
- Histologic remission [ Time Frame: 5 years ] [ Designated as safety issue: No ]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:
- Furrowing, Epithelial hyperplasia, clinical symptoms [ Time Frame: 5 years ] [ Designated as safety issue: No ]Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.
|Study Start Date:||October 2002|
|Study Completion Date:||October 2012|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Drug: Fluticasone Propionate
Flovent vs. placebo daily for 3 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266578
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
Sponsors and Collaborators
|Principal Investigator:||Marc E. Rothenberg, M.D., Ph.D.||Children's Hospital Medical Center, Cincinnati|