Rhinology

Nithin Adappa, M.D.

Quinine for Chronic Rhinosinusitis
Clinical Research – open

Quinine is a bitter molecule that activates multiple bitter taste receptors and stimulates sinonasal epithelial nitric oxide production. The purpose of this study is to examine the efficacy of quinine applied topically to the sinonasal epithelium via lavage as an alternative therapy to treat bacterial rhinosinusitis in patients who have previously undergone functional endoscopic sinus surgery (FESS).

Sinonasal Cancer QOL
Clinical Research – open

The purpose of this project is to form a prospective longitudinal study for patients with new diagnoses of sinonasal cancer. This will evaluate data on patient demographics, treatment modalities, surveillance methods, quality of life, and outcomes. This project will allow for a better understanding of the survival/outcomes of those affected with disease and a statement on the specifics of treatment used (type of surgery and frequently radiation) for this disease.

Bacterial Colonization in Cystic Fibrosis Patients
Clinical Research – open

Our goal is to evaluate 150 patients with early onset pseudomonal colonization and 150 controlled matched CF patients who have either not developed pseudomonal colonization or developed it later in life, and to compare bitter taste receptor polymorphisms between the two populations.

John Bosso, M.D.

Alcohol Intolerance Pre- and Post-ASA Desensitization
Clinical Research – open

This research is being done to find out whether or not aspirin desensitization may also improve tolerance to alcohol in people with Aspirin-Exacerbated Respiratory Disease (AERD).

Phase 3 Dupilumab in Nasal Polyposis with Corticosteroids
Clinical Research – open

This is a randomized, double-blind, 52-week, placebo-controlled efficacy and safety study of dupilumab in patients bilateral nasal polyposis on a background therapy with intranasal corticosteroids.   This protocol evaluates the efficacy of dupilumab 300 mg every 2 weeks compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP).

Phase 2 Ifetroban in AERD
Clinical Research – open

This is a Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to evaluate Oral Ifetroban in Subjects Symptomatic Aspirin Exacerbated Respiratory Disease (AERD). The purpose is to determine the efficacy of ifetroban compared to placebo to improve sino-nasal symptoms and quality of life (QoL) using the Sino-nasal Outcome Test (SNOT-22) score in symptomatic AERD subjects.

Noam Cohen, M.D.

Pathogenesis of Chronic Rhinosinusitis
Clinical Research – open

This study investigates the pathogenesis of chronic rhinosinusitis (CRS). Blood, hair, sinus tissue, sinus musoca, nasal secretions, and saliva are collected from patients with CRS or with pituitary or skull base tumors undergoing sinus surgery. Subjects also undergo taste testing.

Inverted Papilloma: HPV and Tumor Microenvironment in Disease Progression
Clinical Research – open

The goal of this study is to determine the pathogenesis of Inverted Papillomas (IPs) and the etiological role of HPV. Our hypothesis is that HPV is responsible for the initiation of IP, and dysplastic changes and malignant transformation requires viral integration and additional cellular changes, with molecular markers that correlate with histologic grading.  This study will provide insight into the roles of LR and HR HPV in pathogenesis of IP.  We hypothesize that coinfection is common, with HR HPV in benign IP as well, but viral integration would be integral in malignant transformation.

David Kennedy, M.D.

Microbiomes in Management of PostOp CRS
Clinical Research – open

This is a multi-site protocol where Temple University is the lead site. The objective is to obtain mucosal swabs from consenting subjects and send the samples for microbiome analysis at PathoGenius Laboratories. The results of the microbiome analysis will be used to randomize the subjects to a therapy arm: 1) topical of 2) oral antibiotic therapy.

Use of Itraconazole in Refractory Chronic Rhinosinusitis
Chart Review – open

Itraconazole has anti-fungal, anti-inflammatory and anti-angiogenic properties. The purpose of this study is to determine why some patients with CRS benefit from the latter two properties, while others do not.  The targeted population is patients of Dr. David Kennedy’s who have received itraconazole and whose electronic medical records are readily available.  This study involves retrospective data review to identify these patients and the differences between them.

Erica Thaler, M.D.

Obstructive Sleep Apnea Surgery Outcomes
Chart Review – open

This is a retrospective cohort study of adults with moderate to severe OSA who are unable to tolerate positive airway pressure therapy. This is a multi-institutional study with at least 500 subjects, with at least 30 subjects coming from UPenn.

TORS vs HGNS in Obstructive Sleep Apnea
Chart Review – open

Comparison of Outcomes: TORS vs HGNS in OSA Patients with Anteroposterior Collapse on DISE. This is a retrospective chart review study comparing improvement in AHI scores of patients who received TORS or HGNS (hypoglossal nerve stimulation) for obstructive sleep apnea and had AP pharyngeal collapse on DISE.

Inspire-Device Interaction
Chart Review – open

Safety and Efficacy of Hypoglossal Nerve Upper Airway Stimulator in Patients with Cardiac Implantable Electronic Devices and CPAP-Intolerant Severe Obstructive Sleep Apnea. This is a multi-site observational study to evaluate safety and efficacy of hypoglossal nerve upper airway stimulator in patients with cardiac implantable electronic devices. All patients with pre-existing CIED who underwent HNS implant for OSA will be enrolled and a registry database will be maintained.

Diagnostic Validation of DISE
Clinical Research – open

Pilot study for Diagnostic Validation of Drug-Induced Sleep Endoscopy (DISE) in Assessing Pattern of Airway Collapse for Surgical Intervention in Patients with Obstructive Sleep Apnea. The aim of this study is to validate whether the pattern of collapse recorded during DISE mirrors that of natural sleep. Furthermore, we aim to develop a quantitative, in vivo model for airway collapse in order to further our understanding of the pathophysiology of OSA. We will achieve this by comparing the findings from DISE with aerodynamic readings from within the upper airway during natural sleep.

Richard Doty, Ph.D

Quantitative measures of smell and taste function
Chart Review – open

This is a retrospective chart review study to assess associations between demographic and chemosensory test measures among patients seen in the Penn Smell & Taste Center since 1980. We seek to better understand associations between a broad range of demographic and sensory measures and the etiology, natural history, clinical manifestations, and treatment possibilities related to chemosensory disturbances.

Biomarkers in Neural Disorders
Clinical Research – preparing to begin

This study seeks to establish the sensitivity and specificity of an electrically induced trigeminal nerve blink reflex response that appears to be a unique brainstem biomarker of PD. This biomarker has the potential to differentiate early stage PD from normal controls and a number of neural diseases, including early stage Alzheimers disease, progressive supranuclear palsy, and diffuse Lewy Body disease. This study additionally compares the biomarker to olfactory test scores.

Legionella Pneumonia’s Effect on Olfactory Function
Clinical Research – preparing to begin

The purpose of this study is to assess the function of the olfactory system of patients who had Legionnaires’ disease, using the University of Pennsylvania Smell Identification Test (UPSIT).

Nasal Inhalation Influences on Smell Function
Clinical Research – preparing to begin

The purpose of this study is to determine, using a double-blind protocol, whether scores on objective measures of olfactory function improve following 4 months of systematic smelling of odors or of non-odorized air in older persons and in persons with chemosensory dysfunction.   In essence, the study will assess whether “mere exposure” to odorants has the same efficacy as exposure to named odorants, the latter of which likely recruits more cognitive processes, or whether simply concentrated sniffing improves such function.