At a glance
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A Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic Esophagitis
In Brief
A Phase 2 clinical trial evaluating Fluticasone and Placebo for Eosinophilic Esophagitis. Completed, enrolled 42 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Aerosolized swallowed fluticasone 880 mg twice a day
Placebo inhaler swallowed twice a day for 6 weeks