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

Sponsor:	Children's Hospital Medical Center, Cincinnati
Information provided by:	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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug	Drug: Flovent 1760 mcg daily
2: Placebo Comparator	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 prior to endoscopy OR failure of histological improvement as defined by <1 eosinophil per HPF after 2 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 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.

Contacts and Locations

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

Contacts

Contact: Bridget K Buckmeier Butz, M.H.S.A

513-636-5540

bridget.buckmeier@cchmc.org

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229

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:	Cincinnati Children's Hospital ( Marc E. Rothenberg )
Study ID Numbers:	06-10-07
Study First Received:	January 22, 2007
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00426283 History of Changes
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:

Anti-Inflammatory Agents
Respiratory System Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Esophagitis
Digestive System Diseases

Autonomic Agents
Therapeutic Uses
Fluticasone
Esophageal Diseases
Peripheral Nervous System Agents
Gastroenteritis
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 09, 2009