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A Study of Flovent in Patients With Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00426283
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : February 3, 2014
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Rothenberg, MD, Children's Hospital Medical Center, Cincinnati

Brief Summary:
The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).

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
Actual Study Start Date : January 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012


Arm Intervention/treatment
Experimental: Flovent 1760 mcg
Fluticasone propionate 880 mcg twice daily for 3 months
Drug: Flovent
1760 mcg daily
Other Name: Fluticasone propionate

Placebo Comparator: Placebo
Placebo twice daily for 3 months
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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. Percent of Participants With Decreased Cortisol Levels After 3 Months [ Time Frame: 3 months ]
    Blood and saliva cortisol was measured and compared to reference range at 3 months. Participants with measures below the reference range were considered "decreased".

  2. Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent [ Time Frame: 3 months ]
    Strength of the association (odds ratio) of age, body mass index (BMI) z-score , and allergic status with response to Flovent. Allergic status is defined as a history of allergic disease (allergic rhinitis, hay fever, atopic dermatitis, eczema, food anaphylaxis, asthma, or positive skin prick tests). Response is defined as <= 1 eosinophil/high power field in esophageal biopsies.

  3. EoE Score After 3 Months [ Time Frame: 3 months ]
    The gene expression profile is associated with an EoE score algorithm reflecting disease status and severity in a quantifiable number - called the EoE score, based on a core set of 77 diagnostic genes. The EoE score was calculated for Flovent responders and placebo. Higher scores indicate normalization of genes associated with inflammation and fibrosis (disease severity). Therefore higher scores mean a better outcome. The minimum score is zero. There is no maximum score.

  4. Association of Compliance With Therapy and Response to Flovent [ Time Frame: 3 months ]
    Odds ratio was determined to show the strength of the association between compliance with the drug therapy and response to the drug therapy

  5. Percent of Participants With Abdominal Pain After Therapy [ Time Frame: 3 months ]
    Percent of participants responding that they experienced abdominal pain (i.e. they did not respond "never") after therapy. Responses were dichotomized into "Never" and "sometimes".



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Ages Eligible for Study:   3 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00426283


Locations
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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, MD
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Rothenberg, MD, Marc Rothenberg, MD, PhD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov 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: October 19, 2020
Last Verified: September 2020
Keywords provided by Marc Rothenberg, MD, Children's Hospital Medical Center, Cincinnati:
Eosinophilic Esophagitis
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
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