A Phase 2 interventional study of Fluticasone and Placebo in Eosinophilic Esophagitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food.
Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.
This was a double-blind randomized placebo controlled trial to evaluate the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults newly diagnosed with eosinophilic esophagitis (EoE). Participants were randomized to receive aerosolized swallowed fluticasone 880 mcg bid or placebo inhaler swallowed bid for 6 weeks.
Four mid esophageal biopsies were obtained from 10 cm above the squamo-columnar junction; then formalin-fixed and stained with hematoxylin and eosin. All esophageal biopsies were read and scored by a single expert gastrointestinal pathologist. The formalin-fixed paraffin-embedded esophageal biopsies were retrieved and underwent standard major basic protein (MBP) immunofluorescence staining. All special stain slides were then read and scored by another pathologist. 24-hour urine was collected for free cortisol by the standard technique. The original endoscopy was performed before the patient was enrolled in the trial by standard clinical technique. The endoscopy post treatment was done in the clinical research unit by the principal investigator.
Patients kept compliance logs that were reviewed at phone interviews at 2 and 4 weeks time and at the end of study evaluation. Ninety percent compliance was required for study inclusion.
At the end of 6 weeks, a 24-hour urine cortisol was done, and patients underwent a repeat endoscopy while still on treatment. Mid-esophageal biopsies were obtained and evaluated for eosinophil density and mast cell degranulation. At this visit the patients returned dysphagia and side effects questionnaires.
322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
This study's enrollment of 42 is below the median of 66 across 215 interventional studies indexed under Esophagitis.
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Exclusion Criteria:
Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Drug: Fluticasone
Placebo inhaler swallowed bid for 6 weeks
Drug: Placebo
Aerosolized swallowed fluticasone 880 mg twice a day
Also known as: Flonase, Veramyst
Placebo inhaler swallowed twice a day for 6 weeks
Number of Participants With Complete Response to Dysphagia
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"
Time frame: 2 weeks
Number of Participants With Partial or Complete Response to Dysphagia
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?" A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level.
Time frame: 2 weeks
Number of Participants With Complete Histologic Response
A complete histologic response was defined as \>90% decrease in mean eosinophil count/high powered field
Time frame: 2 weeks
Adult patients with a new diagnosis of eosinophilic esophagitis were recruited at the Mayo Clinic Rochester between 10/2005 and 12/2009.
| Milestone | Fluticasone | Placebo |
|---|---|---|
| Started | 21 | 21 |
| Completed | 19 | 15 |
| Not completed | 2 | 6 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Travel | 1 | 1 |
| Withdrew: Scheduling | 1 | 2 |
| Withdrew: Family issues | 0 | 2 |
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"
| participants | Fluticasone | Placebo |
|---|---|---|
| Number of Participants With Complete Response to Dysphagia | 9 | 6 |
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?" A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level.
| participants | Fluticasone | Placebo |
|---|---|---|
| Number of Participants With Partial or Complete Response to Dysphagia | 12 | 7 |
A complete histologic response was defined as \>90% decrease in mean eosinophil count/high powered field
| participants | Fluticasone | Placebo |
|---|---|---|
| Number of Participants With Complete Histologic Response | 13 | 0 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone | — | 0/19 (0%) | 7/19 (36.8%) |
| Placebo | — | 0/15 (0%) | 6/15 (40%) |
| Event | Fluticasone | Placebo |
|---|---|---|
| Esophageal candidiasisGastrointestinal disorders | 5/19 | 0/15 |
| Sore throatGastrointestinal disorders | 2/19 | 3/15 |
| HoarsenessRespiratory, thoracic and mediastinal disorders | 0/19 | 3/15 |
| Age Continuous(years) | Fluticasone | Placebo | Total |
|---|---|---|---|
| Mean | 37.5 (19 to 59) | 35 (20 to 57) | 37.5 (19 to 59) |
| Sex: Female, Male(Participants) | Fluticasone | Placebo | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 18 | 16 | 34 |
| Region of Enrollment(participants) | Fluticasone | Placebo | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
| Food Impaction > 5 minutes(participants) | Fluticasone | Placebo | Total |
|---|---|---|---|
| Participants with Food Impaction | 16 | 17 | 33 |
| Participants without Food Impaction | 5 | 4 | 9 |
| Mean Esophageal Eosinophil Count(eosinophils/high powered field) | Fluticasone | Placebo | Total |
|---|---|---|---|
| Mean | 40 (8 to 100) | 40 (20 to 80) | 40 (8 to 100) |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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