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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02019758 |
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Date of registration:
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18/12/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
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Scientific title:
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Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis |
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Date of first enrolment:
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January 1, 2015 |
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Target sample size:
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129 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02019758 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Evan S Dellon, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion criteria are as follows:
- Age: 16 - 80 years
- Subject is having a clinically indicated endoscopy for suspicious EoE and has been on
twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of
EoE as per consensus guidelines. Cases must have symptoms of dysphagia, persistent
esophageal eosinophilia (= 15 eosinophils in at least one high-power field) after 8
weeks of treatment with a twice daily proton-pump inhibitor, and other competing
causes of esophageal eosinophilia excluded.
Exclusion criteria are as follows:
- Medical instability that precludes safely performing upper endoscopy
- Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in
the stool)
- Concomitant eosinophilic gastroenteritis
- Esophageal narrowing or stricturing that will not allow a standard 9 mm upper
endoscopy scope to pass
- Cancer in the esophagus, stomach, or intestine
- Previous esophageal surgery
- Esophageal varices (dilated blood vessels in the esophagus)
- Current use of blood thinners like Plavix or Coumadin that are not stopped prior to
endoscopy procedures
- Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic
exam. Exclusionary corticosteroid exposure is defined as any swallowed topical
steroids for EoE or systemic steroids for any condition within the four weeks prior to
the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids
are not an exclusion and are allowable.
- Pregnancy
- Inability to read or understand English
Age minimum:
16 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Drug: Fluticasone MDI
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Drug: Placebo slurry
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Drug: Oral Viscous Budesonide
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Drug: Placebo inhaler
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Primary Outcome(s)
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Post-Treatment Maximum Eosinophil Count (Aim 1)
[Time Frame: 8 weeks]
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Post-treatment Dysphagia Score (Aim 1)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Mean Endoscopic Severity Score at Recurrence (Aim 2)
[Time Frame: Symptom recurrence or 1 year after completing the initial 8 week treatment]
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Percentage of Participants With Histologic Response of <15 Eos/Hpf
[Time Frame: 8 weeks]
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Post-treatment Endoscopic Severity (Aim 1)
[Time Frame: 8 weeks]
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Mean Peak Eosinophil Count (Aim 2)
[Time Frame: Symptom recurrence or 1 year after completing the initial 8 week treatment]
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Median Number of Days Until Symptom Recurrence (Aim 2)
[Time Frame: Symptom recurrence or 1 year after completing the initial 8 week treatment]
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Number of Subjects With Histologic Recurrence, Defined as =15 Eosinophils Per High-power Field, at Follow-up Endoscopy.
[Time Frame: Symptom recurrence or 1 year after completing the initial 8 week treatment]
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Post-treatment Symptom Severity (Aim 1)
[Time Frame: 8 weeks]
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Post-treatment Medication Compliance (Aim 1)
[Time Frame: 8 weeks]
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Secondary ID(s)
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R01DK101856
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13-4047
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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