A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis.
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ABSTRACT: OBJECTIVE:To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE). DESIGN:Adults with active EoE (n=76) randomly received 14?days' treatment with either BET 2×1?mg/day (BET1, n=19) or BET 2×2?mg/day (BET2, n=19), or BVS 2×5?mL (0.4?mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16?eosinophils/mm(2?)hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation. RESULTS:Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients. CONCLUSIONS:BET or BVS was highly effective and safe for short-term treatment of EoE. The 1?mg (twice daily) dosage was equally effective as the 2?mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation. CLINICALTRIALSGOV NUMBER:NCT02280616; EudraCT number, 2009-016692-29.
SUBMITTER: Miehlke S
PROVIDER: S-EPMC4789829 | biostudies-literature | 2016 Mar
REPOSITORIES: biostudies-literature
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