View clinical trials related to Rhinosinusitis.
Filter by:Functional endoscopic sinus surgery (FESS) is one of the effective modalities for the treatment of chronic sinusitis, with the advantages of deep approach, light trauma, and less pain. However, because the operation area involves the nose, eyes and cranial region, the surrounding tissue structure is complex and rich in blood vessels and nerves, and the use of epinephrine, intraoperative tissue damage, nerve stimulation, and postoperative inflammation, edema, hemorrhage, and nasal cavity stuffing can cause patients' stress reaction and postoperative pain, resulting in patients' anxiety, depression, and sleep disorders, which can reduce the quality of early postoperative recovery, and affect the patients' rapid postoperative recovery. Esmolol is a selective β1-adrenergic receptor blocker with fast onset of action and short duration of action, which has the ability to reduce heart rate, blood pressure and myocardial protection. In recent years, several studies have found that esmolol not only reduces perianesthesia stress, but also reduces postoperative pain, decreases intraoperative and postoperative opioid requirements, and reduces the incidence of postoperative nausea and vomiting.In addition, intravenous lidocaine infusion has been shown to improve the quality of early postoperative recovery and accelerate postoperative recovery in patients with FESS.However, the dose of the drug administered is unclear and the range of safe infusion doses is narrow, requiring plasma concentration monitoring to prevent toxic reactions to local anesthetics. Its clinical application may lead to prolonged sinus bradycardia, increasing the cardiovascular risk of patients. Therefore, this study was designed to characterize the FESS procedure with the aim of determining that esmolol is not inferior to lidocaine in FESS in terms of the quality of postoperative recovery and is more advantageous in terms of controlling hemorrhage, guaranteeing a clear operative field, and the safety of the medication.
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.
This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray). Study details include: - The study duration will be up to 40 weeks. - The treatment duration will be up to 24 weeks. - The number of visits will be 7.
Primary Objective: - To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting Secondary Objectives: - Describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months). - To assess the healthcare resource utilization of participants with CRSwNP in countries of the Gulf region (number of visits, emergency room (ER), surgery, etc).
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives - To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab - To evaluate the safety of dupilumab and omalizumab
The primary objectives of the study are: - To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time. - To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities The secondary objectives of the study are: - To characterize real-world utilization of DUPIXENT® for patients with CRSwNP - To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP - To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis
The investigators believe that administering Dupilumab during the pre- and peri-operative period of surgery for chronic rhinosinusitis with nasal polyps (CRSwNP) will safely downregulate Type 2 inflammation of the healing sinus environment and will allow for better coordinated and more effective mucosal healing. Specifically, the investigators believe that endoscopic signs and symptoms of recurrence will be reduced in the Dupilumab-treated group, and that this will be reflected in quality of life (QOL). Additionally, by reducing Type 2 inflammation at the time of surgery, Dupilumab may offer an additional benefit by decreasing operative bleeding. The investigators propose to perform a placebo-controlled, prospective, real-world trial in patients with CRSwNP undergoing revision surgery for CRSwNP to verify whether recurrences after endoscopic sinus surgery (ESS) can be prevented by controlling Type 2 inflammation during the peri-operative period using Dupilumab. A series of seven injections of Dupilumab (or placebo) will be administered to symptomatic patients undergoing ESS for CRSwNP. Beginning 4 weeks prior to surgery and continuing for 8 weeks post-surgery, q2 weekly injections will be administered to reduce Type 2 inflammation at time of ESS and during the post-operative recovery period. Principal outcome will be absence of recurrence of mucosal oedema of the sinus cavity as assessed by endoscopy. Secondary objectives will assess Polyp size, sinus symptomatology, quality of life, smell and asthma control. Exploratory analyses will assess microbiome and gene expression profiles to better understand molecular mechanisms implicated in CRSwNP pathophysiology, and to identify the pathways implicated by modulation of Type 2 inflammation.
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.