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A Study of Flovent in Patients With Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426283
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : February 3, 2014
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Flovent Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: 1
Drug: Flovent
1760 mcg daily

Placebo Comparator: 2 Other: Placebo
1760 mcg daily

Primary Outcome Measures :
  1. The Percentage of Participants Who Attained Remission. [ Time Frame: 3 months ]
    Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.

Secondary Outcome Measures :
  1. 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: 3 months ]
  2. To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP. [ Time Frame: 3 months ]
  3. 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: 3 months ]
  4. To Investigate Subject Compliance and Response to FP. [ Time Frame: 3 months ]
  5. To Investigate the Change in Subject Symptoms and Response to FP. [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426283

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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
Marc Rothenberg
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Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marc Rothenberg, Marc Rothenberg, MD, PhD, Children's Hospital Medical Center, Cincinnati Identifier: NCT00426283    
Other Study ID Numbers: 06-10-07
First Posted: January 24, 2007    Key Record Dates
Results First Posted: February 3, 2014
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Marc Rothenberg, Children's Hospital Medical Center, Cincinnati:
Eosinophilic Esophagitis
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents