35 Clinical Trials for Various Conditions
The purpose of this randomized study will be to determine whether topical probiotic sinus irrigations are more effective compared to saline sinus irrigation controls in the treatment of active CRS in patients who have had prior sinus surgery based on subjective and objective outcome measures.
The safest and most effective post-operative pain control regimen after functional endoscopic sinus surgery (FESS) has been the subject of persistent research. This prospective study will compare post-operative pain control when managed either by a defined medication schedule or medication taken on an as-needed basis after functional endoscopic sinus surgery for chronic rhinosinusitis. Prior to surgery, patients will be randomly selected to be in one of two treatment arms. One group will receive instructions to take specific medications (acetaminophen and ibuprofen on a specific schedule post-operatively. The second treatment groups will be instructed to take the same medications but on an as needed basis for pain. Patients will also be provided with an option of a limited supply of narcotic analgesics for pain should they be needed. Post-operative pain control will be assessed by the patient with a pain-diary documenting perceived levels of pain for 10 days post-operatively using a validated visual analog scale. At the conclusion of the study the records of medications taken along with pain responses will be compared between groups
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
This is a cross-sectional study of up to 100 subjects who are undergoing clinically indicated sinus procedures to treat chronic rhinosinusitis. Participants will be asked to donate leftover sino-nasal secretions, sino-nasal tissue and blood as well as undergo partial characterization. As optional extensions of the main study, participants may also undergo a biopsy of extra sino-nasal tissue for additional tissue analysis and/or a more detailed characterization visit performed in the UCSF Airway Center Research Center (ACRC).
This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others.
The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions may have beneficial effects over isotonic saline rinses; however prior clinical studies on this topic have been inconclusive and limited due to highly variable inclusion criteria, large variability in the volume and concentration of irrigation solution, and inconsistent outcome measures. The goal of the study is to utilize a cross over study design to directly compare the impact of two different types of saline irrigation. Primary aim: Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the investigators expect participants will experience greater symptom improvement with hypertonic saline rinses as compared to isotonic saline irrigations. Hypothesis: Participants will have greater improvement in patient reported outcome measures (SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered isotonic saline irrigations.
In the United States, more than 30 million people are diagnosed with sinusitis each year. Moreover, chronic sinusitis effects approximately 15% of the U.S. population and is one of the most common chronic illnesses in America. Budesonide and mometasone nasal sprays are used to relieve sneezing, runny, stuffy, or itchy nose caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). The objective of this study is to determine the incidence of cortisol suppression with the use of mometasone irrigations in varying doses. Low levels of cortisol can cause weakness, fatigue, and low blood pressure. In using nasal sprays, a drug may enter the body's circulation through direct local absorption in the nasal mucosa or oral absorption of any swallowed medication. Some people can reduce symptom severity using medication, including antihistamines and anti-inflammatory drugs. Nasal irrigation - the flooding of the sinus cavity with warm saline solution - can help to reduce sinus congestion and is often recommended by otolaryngologists for a variety of sinus conditions. The goal of nasal irrigation is to clear excess mucus and foreign debris out of the sinuses, and to moisturize the mucosal membrane. The practice has been subjected to clinical testing and has been found to be safe and beneficial with no apparent side effects. The addition of budesonide to nasal irrigations has become common practice in the treatment of chronic rhinosinusitis. Mometasone has been shown to be an alternative to budesonide with increased local effects and lower absorption by the body. Studies have shown that saline irrigation treatments show greater effects versus saline spray for providing short-term relief of chronic nasal and sinus symptoms. There is limited data on the use of mometasone in nasal irrigations. Subjects to be included in the study are those with a diagnosis of chronic rhinosinusitis, with or without nasal polyps and who have had prior endoscopic sinus surgery. This study will test 3 different concentrations of mometasone in a nasal irrigation. Patients will receive either 1 milligram mometasone in their nasal irrigations, 2 milligrams of mometasone, or 4 milligrams of mometasone. The dose assignment will be determined by the treating physician. After 12 weeks of entering this study and use of the mometasone irrigations, there will be a blood draw to compare morning cortisol levels to a baseline blood draw.
The aim of this study is to evaluate the effect of the addition of epinephrine to bilateral real time ultrasound guided pterygopalatine ganglion blocks on intra-operative bleeding and blood loss during functional endoscopic sinus surgery (FESS).
Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant disease burden. The recommended medical management of CRS includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the efficacy and safety of INCS are well-established for the long-term management of CRS, penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive CRS patients.
Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.
The objective of the ASCEND Study is to assess the safety, performance, and efficacy of the Intersect ENT UP Drug-Coated Device when used in chronic rhinosinusitis (CRS) patients undergoing balloon dilation of frontal sinus ostia (FSO)
Benralizumab will be used in a placebo controlled randomized study to treat severe chronic rhinosinusitis with nasal polyps
The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; produce detectable improvements in validated measures of CRS including the SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and provide beneficial effects on readily measured markers of sinonasal inflammation and infection (IP-10, IL-8, and Pseudomonas CFUs).
The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in asthma patients who are undergoing treatment with reslizumab. A secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their CRS symptoms.
The goal of the study is to compare postoperative symptom scores and endoscopy findings between in patients who receive either nasal saline rinses, saline + budesonide, and saline + topical antibiotics and budesonide following endoscopic sinus surgery.
The purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.
Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS. The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events. In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evaluating the effect of NSAID in ESS during the post-operative period. The overarching goal of this investigation is to decrease opioid use in post-operative pain control following ESS.
Chronic rhinosinusitis is an inflammatory disease of the sinonasal mucosa with significant impact and limited treatment options. Chronic rhinosinusitis (CRS) poses an important public health problem and causes a large impact on individual quality of life. Studies of CRS have been limited by access to tissue, the complexity of the sinonasal physiology, a lack of available biomarkers, the absence of useful animal models, a paucity of cohorts with biological samples for analysis, and limited well-designed clinical trials or investigations of immune function. Therefore, novel strategies for identifying biological mechanisms underlying this disease are in great need. Using prospective samples from well characterized subjects, the investigators intend to profile the mucosa associated-bacteria in the nose and sinuses. In parallel, using sinus tissue from patients undergoing surgery, the site will interrogate the epithelium for mucosal immune function to understand host-microbe interaction. This study hypothesizes that the microbial profile of the sinuses initiates an immune responses which leads to chronic inflammation in susceptible people. This study would provide the first comprehensive data on what bacteria are present in the nose and sinus and could lead to important knowledge useful in sinonasal disease.
This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.
The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are: 1. To see what mepolizumab does to suppress inflammation of the human cells. 2. To see what mepolizumab does to maintain barrier integrity of epithelial cells
Multicenter, phase III, randomized, blinded, controlled, parallel group.
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
A prospective, single-arm, post approval pilot study.
The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal polyps in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo.
The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. The Sinus and Nasal Quality of Life Survey (SN-5), a validated tool, will be used to track symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent an improvement in symptom control. In this study, the SN-5 at one year post intervention will be the primary endpoint. Secondary endpoints include complications, revision surgery, and post operative endoscopy scores.
The purpose of this study is to determine the most effective route to administer steroids to patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with nasal polyps (CRSsNP). The investigators would like to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators propose to test the hypothesis that for patients with radiographically proven CRSsNP, routine medical therapy consisting of a short course of systemic corticosteroids is superior to topical corticosteroids for relieving inflammation and the symptoms of CRS.
Chronic rhinosinusitis (CRS) is the most common chronic medical condition that affects Americans between 18-44 years of age. While significant advances have been made in the understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not translated into widespread changes in how physicians manage adult or pediatric CRS. The focus of this study is intended to develop testing methods to improve the objectivity and specificity of diagnosis and allow for individualized therapy with less invasive, customized treatments instead of the traditional, empiric based, and radically exenterative therapies commonly employed in clinical practice. Specifically, it is now known that many patients with CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the bacterial biofilms located within their sinus cavities compared to healthy patients. The specific hypothesis behind the proposed research is that the presence of NTHI biofilms, which are known to be highly recalcitrant, are positively correlated with the development of CRS and that unique lipooligosaccharides and inflammatory byproducts obtained from nasopharyngeal lavage fluids and/or swabs of sinus secretions may be used as a non-invasive biomarker for CRS. As a result, patients with symptoms of CRS specifically associated with NTHI biofilms could possibly obtain a non-invasive test in the physician's office that would allow the clinician to make a more accurate diagnosis and objectively follow each patient's responsiveness to customized therapy.
Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays in order to detect bacteria, fungi and viruses. Ten control patients with normal sinuses will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques.
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * 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 * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo