22 Clinical Trials for Various Conditions
Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication. The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery (FESS). As the disease course is generally idle, prolonged medical treatment guidelines are for antibiotic treatment, prescribed accordingly following appropriately obtained nasal cultures, lasting weeks with or without additional topical or oral steroid treatment. While FESS success rate is a general notion, a failure rate of primary FESS is as high as 2-24%2, with a Cochrane review even suggesting that FESS though a safe procedure is of no benefit more than medical management. With that in mind as we address the failed FESS, new bacteria emerge. The new bacteria in CRS are Coagulase-negative staphylococci were the most common isolates (36%), followed by Staphylococcus aureus (25%), Streptococcus viridans (8.3%), Corynebacterium (4.6%), and anaerobes (6.4%). Patients not relieved by primary FESS demonstrate a significant rise in Pseudomonas and MRSA bacteria positive cultures. Moreover surgical success for patients with Staphylococcus aureus and Pseudomonas aeruginosa positive cultures is usually reduced. Bacterial killing, by usage of light-activated agents such as Indocyanine Green (ICG) with exposure to the specific wavelength, eventually produces bacterial killing. Mechanisms primarily involved are production of reactive oxygen species (i.e. singlet oxygen and free radicals) which can then kill bacteria. ICG by itself does not have any bacterial killing effect. Low level laser therapy (LLLT) was shown to be effective as a bactericidal by single and multiple wave exposures. The study purpose is to treat CRS with an alternative to antibiotics, thus sparing volunteers from prolonged antibiotics use and its possible side effects, not to mention the cost and growth of resistant bacteria. We believe that by combining ICG with light or even by light alone we can produce you a beneficial effect. Although this has been shown to kill bacteria in lab or animal studies it is still investigational for humans. The study will have two arms: ICG + laser and laser only arm. ICG will be applied locally in the nasal passage (internally) followed by laser activation with a power setting of 6W. The laser will be activated with a diffuser mode meaning light of a specific known wavelength will be delivered evenly in the nasal cavity and not as a beam. Laser only treatment plan will be the same only without ICG. Volunteers will be assigned to one of the groups randomly meaning you have a 50% chance of enrolling to each treatment group. Volunteers will not know to which group. Weekly visits with a total of three visits will follow. With each visit Volunteers will receive additional treatment as the initial treatment was and a nasal culture will be taken. Volunteers will have to fill a questionnaire with each visit.
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.
The overarching objective of this study is to determine the clinical effectiveness of dupilumab for the treatment of CRS that includes several potential disease endotypes with the exclusion of the nasal polyp cluster that has previously been determined. The additional information gained from secondary and exploratory outcomes will help provide important insight for applied research studies and may also provide practical guidance to clinicians on how to select patients for treatment.
The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. The investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. All patients enrolled in this study will have chronic sinusitis without asthma.
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
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.
The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.
This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. However, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. For some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. Other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.
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
To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).
The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids. Oral steroids are the mainstay of medical management for patients with CRSwNP. However, recent studies have shown that doxycycline helps improve symptoms as well by reducing inflammation and killing common bacteria that can cause symptoms. This study is the first to evaluate this combination regimen.
Primary Objective: To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo. Secondary Objectives: To evaluate effect of dupilumab with regards to: * symptoms of sinusitis, * sinus computed tomography (CT) scan, * NPS in the sub-group of participants with co-morbid asthma, * Safety and tolerability.
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.
Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP. The study was initially approved as a Phase Ib/II, but only the Phase Ib portion was completed as part of this protocol.
Chronic rhinosinusitis is a common disease that effects millions of people world wide. Despite its frequency it is unclear what treatment options are the best for these patients. Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study to see if oral steroids benefit the treatment outcomes in those patients with chronic rhinosinusitis without nasal polyps. In addition this study will look to see if a short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference in outcomes.
Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce inflammation in a variety of tissues. Verapamil has also been shown to improve eosinophilic inflammation in an animal model of asthma and also functions as a P-glycoprotein(P-gp) inhibitor. A major subtype of chronic rhinosinusitis(CRS) is characterized by eosinophilic inflammation as well as P-gp overexpression. The goal of this study is to therefore see whether Verapamil may be used to treat CRS.
The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).
Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.
The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.