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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flovent 1760 mcg | Experimental | Fluticasone propionate 880 mcg twice daily for 3 months |
|
| Placebo | Placebo Comparator | Placebo twice daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flovent | Drug | 1760 mcg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 \ | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 3 months |
| Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc E. Rothenberg, M.D., Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Denver | Aurora | Colorado | 80045 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24768678 | Derived | 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. |
| Label | URL |
|---|---|
| Cincinnati Center for Eosinophilic Disorders | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flovent 1760 mcg | Drug Flovent : 1760 mcg daily |
| FG001 | Placebo | Placebo twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flovent 1760 mcg | Drug Flovent : 880 mcg twice daily |
| BG001 | Placebo | Placebo twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 \ | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
|
|
From consent to cessation of treatment which was approximately 4 months
Adverse events were reported according to the MedDRA System Organ Class
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flovent 1760 mcg | Drug Flovent : 1760 mcg daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Disorders | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc E Rothenberg | Cincinnati Children's Hospital Medical Center | 513-636-7177 | rothenberg@cchmc.org |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Other | Placebo |
|
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 months |
| 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. | 3 months |
| 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 | 3 months |
| 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". | 3 months |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | 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". | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | 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. | Analysis population is restricted only to those that were given Flovent for the purpose of determining whether these specific variables are associated with response to drug | Posted | Number | 95% Confidence Interval | Odds Ratio | 3 months |
|
|
|
| Secondary | 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. | Population includes only responders to Flovent and all participants finishing the study on Placebo. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | 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 | Analysis population is restricted only to those that were given Flovent for the purpose of determining whether compliance with therapy was associated with response to drug | Posted | Number | 95% Confidence Interval | Odds Ratio | 3 months |
|
|
|
| Secondary | 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". | Posted | Number | percentage of participants | 3 months |
|
|
|
| 28 |
| 0 |
| 28 |
| 19 |
| 28 |
| EG001 | Placebo | Placebo : daily | 0 | 14 | 0 | 14 | 9 | 14 |
| General Disorders | Eye disorders | Non-systematic Assessment |
|
| General Disorders | Gastrointestinal disorders | Non-systematic Assessment |
|
| General Disorders | Immune system disorders | Non-systematic Assessment |
|
| General Disorders | Infections and infestations | Non-systematic Assessment |
|
| General Disorders | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| General Disorders | Investigations | Non-systematic Assessment |
|
| General Disorders | Nervous system disorders | Non-systematic Assessment |
|
| General Disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| General Disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|