A Study of Flovent in Patients With Eosinophilic Esophagitis - Full Text View

Sponsor:	Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00426283

Purpose

The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone propionate (Flovent), in subjects with eosinophilic esophagitis (EE).

Condition	Intervention	Phase
Eosinophilic Esophagitis	Drug: Flovent Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

To investigate the ability of 1760mcg fluticasone propionate (FP) swallowed from a metered-dose inhaler (MDI) to induce remission of eosinophilic esophagitis (EE) (highest count of eosinophils per HPF for all esophageal biopsies to < 1 cell per HPF. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate the safety of 1760mcg FP in the treatment of EE using measurement of serial salivary cortisol levels and adverse reaction data. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: Yes ]
To investigate the relationship between subject age, height, weight, allergic status and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
To investigate the relationship between gene expression, blood levels (CBC, serum IL-5, eotaxin-3 and IgE) eosinophil phenotype, (via flow cytometry and functional responses) and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
To investigate subject compliance and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
To investigate the change in subject symptoms and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Drug	Drug: Flovent 1760 mcg daily
Placebo Comparator: 2	Other: Placebo 1760 mcg daily

Eligibility

Ages Eligible for Study:	3 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent for study by subject, or parent/guardian if subject is a minor. Assent will be obtained from all minors 11 years of age and older.
Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per high power field (400x) in the proximal or distal esophagus validated by a pathologist at CCHMC.
Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet is not indicated.
Have undergone a minimum 3 months of elimination diet as indicated by skin-prick testing without detectable resolution by repeat endoscopy with biopsies demonstrating persistent EE OR subject/parental refusal to follow elimination diet. If the subject/parent refuses the elimination diet, they are eligible for this study.
Treatment with a proton-pump inhibitor for at least two months (rounded to nearest month) prior to endoscopy OR failure of histological improvement as defined by < 1 eosinophil per HPF after 2 month (rounded to nearest month) trial of proton pump inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to rule out the possibility of GERD.

Exclusion Criteria:

History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections during exposure to Flovent
Unable to cooperate with use of MDI
Pregnant females
Concurrent or recent (within 3 months) use of systemic corticosteroids.
Unable to swallow medicines (i.e., fed only by gastrostomy tube).
Comorbid eosinophilic disorders.
Previously treated with swallowed glucocorticoid for EE within 3 months of the screening visit. Nasal glucocorticoids taken for EE are permitted.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426283

Locations

United States, Colorado
The Children's Hospital of Denver
Aurora, Colorado, United States, 80045
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator:

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

Children's Hospital Medical Center, Cincinnati

More Information

Additional Information:

Cincinnati Center for Eosinophilic Disorders This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00426283 History of Changes
Other Study ID Numbers:	06-10-07
Study First Received:	January 22, 2007
Last Updated:	December 1, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Eosinophilic Esophagitis

Additional relevant MeSH terms:

Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012