Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275561
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2006-01-10
Brief Title:
Topical Steroid Treatment for Eosinophilic Esophagitis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic Esophagitis
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None