View clinical trials related to Sinusitis.
Filter by:Objective: The objective of this study is to evaluate a steroid-embedded Terpolymers polymer implant of L-lactide and trimethynele carbonate (TCM) at the level of disease control in patients with eosinophilic and central compartment chronic rhinosinusitis (CRS) after placement of the endonasal device, compared to a control group (placebo). The secondary objectives of this study are to assess comfort, perception of improvement and satisfaction, as well as adverse events. Methods: A randomized controlled trial will be carried out, with a blinded participant, therapist and evaluator. Patients over 18 years of age, with chronic rhinosinusitis (CRS) who have already undergone endoscopic sinus surgery (CENS), but who do not have the disease under control and, therefore, with an indication for a new CENS, will be selected. Participants will come from the otorhinolaryngology outpatient clinic of the academic and public service of the University of São Paulo - USP. Eligible patients will receive either the Terpolymers L-lactide and trimethynele carbonate (TCM) polymer implant placement or the placebo polymer. The primary outcome will be the control of the symptoms of chronic uncontrolled rhinosinusitis that will be evaluated through the NOSE Questionnaire, a nasal endoscopic evaluation based on the Lund-Kennedy criteria and the SNOT-22 Questionnaire. The sample size calculation was performed based on a difference between the intervention and placebo groups of 30% for cases that achieved disease control, resulting in a sample of 36 participants (18 in each group). Data will be analyzed using mixed linear models.
This study aims to investigate the effect of adding of integrated physiotherapy program to the conservative medical therapy on quality of life and pressure pain threshold (PPT) in chronic rhinosinusitis patients. Patients in this study will be randomly assigned into 2 groups. Group A (control group) will receive conservative medical treatment only which prescribed by Ear, Nose and Throat (ENT) specialist, while group B (experimental group) will receive the conservative medical treatment prescribed by ENT specialist in addition to physiotherapy program. Quality of Life (QoL) will be evaluated by Rhinosinusitis Disability Index (RSDI) and PPT will be evaluated by digital algometer at the baseline and immediately after the end of tenth session of treatment for both groups.
This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
The prevalence of chronic rhinosinusitis in China is about 8%, and some patients still suffer from recurrences after surgery and drug treatment. Monoclonal antibody is considered to be a new drug strategy that can significantly improve the control rate of such patients, but there is a lack of markers to guide the selection of monoclonal antibodies. The price of monoclonal antibody is expensive, which calls for screening markers for predicting the efficacy of monoclonal antibody and precisely implementing this treatment strategy. In addition, it can also improve the quality of life of patients and reduce the social and economic burden. Beijing Tongren Hospital, Capital Medical University recently completed a randomized, double-blind, placebo-controlled, phase II clinical study which included multiple subcutaneous administration of CM310 recombinant humanized monoclonal antibody injection in patients with chronic sinusitis and nasal polyps to evaluate the efficacy and safety as well as the pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy(NCT04805398). The therapeutic target of CM310 recombinant humanized monoclonal antibody injection is IL-4R. The unblinded data showed significant differences in the efficacy of the subjects and we started the investigator-initiate trial (IIT) study aiming at investigating the remaining samples of the project and carrying out a biomarker study to screen and predict the efficacy of IL-4R monoclonal antibody.
Chronic Rhinosinusitis (CRS) is a chronic inflammatory condition of the nasal passage and paranasal sinuses that places significant burden on affected patients and global healthcare systems. Current treatments for CRS such as long-term antibiotics, anti-inflammatory drugs, and surgery often reduce symptoms and signs of disease temporarily, however long-term results are much less satisfactory. Recently, the theory of a damaged microbiome (dysbiosis) as a cause or promoting factor behind CRS has gained increasing evidence from the scientific community. A condition of the gut with microbial dysbiosis (c.difficile) has previously employed microbiota transplant treatment with great success in long-term health outcomes. Such treatments are shown to repopulate bacterial microenvironment and restore protective commensal bacterial load. A pilot study conducted by this study team trialed a novel intervention of a Nasal Microbiota Transplant in a small group of participants. Preliminary results suggested significantly improved CRS symptoms after treatment with a healthy donor microbiota transplant, compared to the pre-transplant baseline. The addition of a randomized-control trial with inclusion of a placebo group is the next step. In this study, investigators aim to perform a two-arm, double-blinded, phase II randomized controlled clinical trial in order to assess the efficacy of a Nasal Microbiota Transplant against a placebo in a cohort of CRS patients without Nasal Polyps (CRSsNP).
Chronic rhinosinusitis that recurs after adequate surgery and conventional medical treatment is called refractory chronic rhinosinusitis (RCRS). Omalizumab and oral glucocorticoid therapy can play an important role in the treatment of RCRS, but there is still a lack of comparative studies on the efficacy and safety of the two. In addition, biomarkers are a hotspot in RCRS research, but there is still a lack of studies on changes in marker expression with disease progression and treatment. In this study, patients aged 18-70 who were diagnosed with CRS were consecutively enrolled, and the patients were divided into RCRS and non-RCRS groups according to pathological results. The patients in the RCRS group were randomly divided (1:1:1) into the nasal spray hormone therapy group, the nasal spray hormone therapy + oral hormone therapy group, and the nasal spray hormone therapy + omalizumab therapy group by a multi-center, randomized, controlled study. The patients were treated for 6 months and followed up for 6 months after treatment. Clinical data such as symptom score and endoscopic score before and after treatment were collected, adverse events were recorded, and the differences in efficacy and safety among the groups were compared. Non-invasive samples such as nasal secretions and exfoliated cells were collected, and the expression and variation of different immune intrinsic markers were explored combined with follow-up results. The development of this project contributes to the establishment of a precise diagnosis and treatment system for refractory chronic sinusitis.
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups to compare the effect of Roflumilust administration with the effect of systemic and local corticosteroids on patients with chronic rhinosinusitis with nasal polyposis
TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.
The primary purpose of this pragmatic randomized clinical trial is to examine whether the addition of a phone-based multicomponent environmental intervention customized for Houston public housing residents with asthma will result in statistically significant improvements in key measures of health, quality of life, and resilience.
Proof-of-concept study with a novel nasal spray in chronic rhinitis or chronic sinusitis. The study will involve 25 patients completing the study for a per protocol analysis.