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A Study of Flovent in Patients With Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Flovent

Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis

Eligibility Criteria

3 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Children's Hospital of Denver
Cincinnati Children's Hospital Medical Center
Children's Hospital of Philadelphia
University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Flovent 1760 mcg

Placebo

Arm Description

Fluticasone propionate 880 mcg twice daily for 3 months

Placebo twice daily for 3 months

Outcomes

Primary Outcome Measures

Percentage of Participants Who Attained Remission.

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

Percent of Participants With Decreased Cortisol Levels After 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

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

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

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

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".

Full Information

NCT ID

NCT00426283

First Posted

January 22, 2007

Last Updated

September 24, 2020

Sponsor

Marc Rothenberg, MD

1. Study Identification

Unique Protocol Identification Number

NCT00426283

Brief Title

A Study of Flovent in Patients With Eosinophilic Esophagitis

Official Title

A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

January 2007 (Actual)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marc Rothenberg, MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flovent 1760 mcg

Arm Type

Experimental

Arm Description

Fluticasone propionate 880 mcg twice daily for 3 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo twice daily for 3 months

Intervention Type

Drug

Intervention Name(s)

Flovent

Other Intervention Name(s)

Fluticasone propionate

Intervention Description

1760 mcg daily

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Percentage of Participants Who Attained Remission.

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Percent of Participants With Decreased Cortisol Levels After 3 Months

Description

Blood and saliva cortisol was measured and compared to reference range at 3 months. Participants with measures below the reference range were considered "decreased".

Time Frame

3 months

Title

Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent

Description

Time Frame

3 months

Title

EoE Score After 3 Months

Description

Time Frame

3 months

Title

Association of Compliance With Therapy and Response to Flovent

Description

Odds ratio was determined to show the strength of the association between compliance with the drug therapy and response to the drug therapy

Time Frame

3 months

Title

Percent of Participants With Abdominal Pain After Therapy

Description

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".

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Children's Hospital of Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24768678

Citation

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.

Results Reference

derived

Links:

URL

http://www.cchmc.org/cced

Description

Cincinnati Center for Eosinophilic Disorders

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A Study of Flovent in Patients With Eosinophilic Esophagitis

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