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Sinusitis clinical trials

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NCT ID: NCT05131464 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of CM310 in patients with CRSwNP.

NCT ID: NCT05083741 Recruiting - Clinical trials for Chronic Rhinosinusitis

Comparison of Chitodex Gel vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis

Start date: December 27, 2021
Phase:
Study type: Observational

The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.

NCT ID: NCT05063981 Recruiting - Asthma Clinical Trials

Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma With or Without CRSwNP.

Start date: November 25, 2021
Phase:
Study type: Observational

Patients with severe or difficult-to-treat asthma represent a small amount of total asthmatic patients, but weight on the national health system for the costs of disease management. Chronic rhinosinusitis with nasal polyposis, which the Italian severe/uncontrolled asthma registry reported with a prevalence of 30%, represents a comorbidity that significantly impact lung function and asthma control in severe asthma. Recent evidence indicates that there is a consistent heterogeneity regarding mucosal alterations present in subjects with nasal polyposis involving different pathways: inflammatory cells, remodeling, T cell activation, local IgE production, alteration induced by interactions between microorganisms and epithelial cells.

NCT ID: NCT05015530 Recruiting - Microbiome Clinical Trials

Impact of Symbiofilm On Nasal Microbiota

ISONAM
Start date: December 12, 2022
Phase:
Study type: Observational

Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%) isolated from marine bacteria. In vitro, Symbiofilm® inhibits at early stage biofilm formation from bacteria found to be more prevalent and abundant in CRS patients (e.g. Staphylococcus aureus, Pseudomonas aeruginosa). This exploratory study is designed with aim to determine if the antibiofilm properties of Symbiofilm® may modify sino-nasal microbiota, impacting α and/ or β diversities.

NCT ID: NCT05009758 Recruiting - Asthma Clinical Trials

Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps

PREMIUM
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely "united airways", which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.

NCT ID: NCT04852562 Recruiting - Nasal Polyps Clinical Trials

The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps

EMRESSECRS
Start date: December 6, 2020
Phase: N/A
Study type: Interventional

Functional endoscopic sinus surgery (FESS) is the pimary surgical treatment of CRS, characterized with the preservation of nasal structure and function.But the control of disease by surgery has been unsatisfactory. Recent studies have shown that patients with recurrent CRSwNP (usually with severe eosinophilic inflammation), more radical surgery may be more effective. The purpose of this prospective and randomized study is to determine the effect of endoscopic sinus surgery for extensive mucosal removal in patients with eosinophilic chronic rhinosinusitus with nasal polyps.

NCT ID: NCT04670172 Recruiting - Clinical trials for Chronic Rhinosinusitis (Diagnosis)

Real-Life Chronic Rhinosinusitis Outcome Registry

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.

NCT ID: NCT04645511 Recruiting - Clinical trials for Eustachian Tube Dysfunction

Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, randomized, placebo-controlled, double-blinded clinical study. The balloon sinuplasty treatment is compared to placebo effect in chronic or recurrent maxillary sinusitis. The purpose is to find out the efficacy of balloon sinuplasty of maxillary sinuses and the patients who get the best benefit from balloon sinuplasty. The investigators also want to find out if balloon sinuplasty of maxillary sinuses improves Eustachian tube dysfunction. The study is executed in the Department of Ear and Oral Diseases, Tampere University Hospital. 120 patients who have either recurrent acute or chronic rhinosinusitis without nasal polyposis and whose sinusitis is limited mainly into maxillary sinuses, are recruited in the study. The patients are allocated either into the chronic maxillary sinusitis (60 patients) or the recurrent maxillary sinusitis (60 patients) branch of the study. Then, the patients are consecutively randomized into two treatment groups in the proportion of 1 to 1: A) Balloon sinuplasty group and B) Placebo group. The treatment is performed according to the patient's group status and all the patients are followed 12 months postoperatively. The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is going to be measured primarily with the Sino-Nasal Outcome Test (SNOT-22). In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment will be measured primarily with the number of acute rhinosinusitis infections. Besides this, number of antibiotic treatments and sick leaves are inquired, Visual Analog Scale (VAS) and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) are used, rhinomanometry, Cone Beam Computed Tomography (CBCT), tympanometry, tubomanometry, nasal endoscopy and general evaluation of the patients clinical ORL-status are performed. Also pre- and postoperative biopsies are taken from the middle turbinates.

NCT ID: NCT04628442 Recruiting - Asthma Clinical Trials

Tissue Immune Interaction in Nasal Polyposis

TIP
Start date: November 10, 2020
Phase:
Study type: Observational

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).

NCT ID: NCT04619160 Recruiting - Clinical trials for Sinus Infection Chronic

Propofol Versus Sevoflurane During FESS

Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

Good surgical conditions are crucial for an optimal surgery result and safe procedure. Minimal blood loss in the surgical field is one of the most important conditions to maintain a good visualization, especially in surgeries with a small surgical field such as a FESS (functional endoscopic sinus surgery). The perioperative blood loss is determined by the main arterial and venous pressure, the local pressure and the capillary vascular filling pressure. It has been proposed that propofol is a venodilator, which increases the blood flow, but decreases the capillary pressure. On the contrary, sevoflurane might act mainly on the arterioles, which causes an increase in the capillary pressure. In a previous study it has been demonstrated that despite blood pressure maintenance, propofol causes less bleeding during spinal surgery than sevoflurane. The main aim of this study was to compare both anaesthetics on the perioperative bleeding and haemodynamics during FESS. Secondary, the postoperative nausea, vomiting, pain scores, surgery duration and length of stay at the post-anesthesia care unit will be evaluated.