Advanced Clinical ENT Research of Kentucky and Southern Indiana
Our Research Center was developed at our Dupont office in 2002 with a core group of seven physicians. We have now grown to include our Brownsboro & New Albany offices and 16 physicians that participate in Clinical Research. We are excited to offer our patients and referring physicians an opportunity to participating in cutting edge medical products and services for the diagnosis and management of ear, nasal and sinus disorders.
Sound Pharmaceuticals: SPI-1005 for the Treatment of Patients With Meniere’s Disease
This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere’s disease.
Astellas Pharmaceuticals Global: A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)
The primary purpose of this study is to evaluate the safety and tolerability of ASP0598 Otic Solution. This study will also evaluate the efficacy of ASP0598 Otic solution.
Sanofi: Chronic Rhinosinusitis without Nasal Polyps
To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo
AstraZeneca: Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 1)
This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll approximately 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 60 patients. The study follow-up duration is 28 weeks.
