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.
Cumberland Pharmaceuticals: Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.
Inspire Medical Systems: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.
OptiNose US, Inc: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis With or Without the Presence of Nasal Polyps
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic sinusitis (CS) with or without nasal polyps.
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.
Hill Dermaceuticals, Inc.: Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
This study involves two sequential portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in the first portion of the study will have active fungal infection of the ear(s) and will be treated with either Miconazole Oil or the Vehicle for 14 days twice daily, 5 drops into the ear(s) per dose. The subjects enrolled in the open-label portion of the study may or may not have active fungal infection of the ear(s), and will be given the Miconazole Oil active drug following the same application of 5 drops into the ear(s) twice daily for 14 days.
The intention of the study is to evaluate the efficacy of Miconazol Oil on fungal infection of the ears when applied using 5 drops into the ear(s) twice daily for 14 days continuously. This study also intends to show safety of Miconazole Oil 5 drops into each ear twice a day for 14 consecutive days.
Otonomy: Unilateral Tinnitus
The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.
Sanofi: Chronic Rhinosinusitis without 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
Sanofi: Acute Fungal Rhinosinusitis
To evaluate the ability of dupilumab to reduce the need for rescue therapy with systemic corticosteroids (SCS) or surgery of AFRS in patients with AFRS who previously have had surgery for AFRS