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
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|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: Flovent Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Flovent 1760 mcg
Fluticasone propionate 880 mcg twice daily for 3 months
1760 mcg daily
Other Name: Fluticasone propionate
Placebo Comparator: Placebo
Placebo twice daily for 3 months
- 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.
- 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".
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|Ages Eligible for Study:||3 Years to 30 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Principal Investigator:||Marc E. Rothenberg, M.D., Ph.D.||Children's Hospital Medical Center, Cincinnati|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Marc Rothenberg, MD, Marc Rothenberg, MD, PhD, Children's Hospital Medical Center, Cincinnati|
|Other Study ID Numbers:||
|First Posted:||January 24, 2007 Key Record Dates|
|Results First Posted:||February 3, 2014|
|Last Update Posted:||October 19, 2020|
|Last Verified:||September 2020|
Digestive System Diseases
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents