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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

Tracking Information
First Submitted Date  ICMJE January 22, 2007
First Posted Date  ICMJE January 24, 2007
Results First Submitted Date  ICMJE December 16, 2013
Results First Posted Date  ICMJE February 3, 2014
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE January 2007
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2007)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • 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".
  • 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.
  • 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.
  • 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
  • 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".
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2007)
  • To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.
  • To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.
  • 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.
  • To Investigate Subject Compliance and Response to FP.
  • To Investigate the Change in Subject Symptoms and Response to FP.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Flovent in Patients With Eosinophilic Esophagitis
Official Title  ICMJE A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • Drug: Flovent
    1760 mcg daily
    Other Name: Fluticasone propionate
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Flovent 1760 mcg
    Fluticasone propionate 880 mcg twice daily for 3 months
    Intervention: Drug: Flovent
  • Placebo Comparator: Placebo
    Placebo twice daily for 3 months
    Intervention: Other: Placebo
Publications * Butz BK, Wen T, Gleich GJ, Furuta GT, Spergel J, King E, Kramer RE, Collins MH, Stucke E, Mangeot C, Jackson WD, O'Gorman M, Abonia JP, Pentiuk S, Putnam PE, Rothenberg ME. Efficacy, dose reduction, and resistance to high-dose fluticasone in patients with eosinophilic esophagitis. Gastroenterology. 2014 Aug;147(2):324-33.e5. doi: 10.1053/j.gastro.2014.04.019. Epub 2014 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2013)
42
Original Enrollment  ICMJE
 (submitted: January 22, 2007)
40
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00426283
Other Study ID Numbers  ICMJE 06-10-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Rothenberg, MD, Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Marc Rothenberg, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP