View clinical trials related to Rhinosinusitis.
Filter by:Acute respiratory tract infections (ARTIs), such as acute rhinosinusitis (ARS) and acute otitis media (AOM), are common worldwide and caused by viruses or bacteria entering the body through the mouth and nose. AOM frequently occurs in young children and is caused by bacterial reflux into the middle ear. ARS is a relatively common ARTIs and can occur at many ages. To accurately diagnose disease, careful clinical examination and accurate clinical judgment are required, as making a reasonable treatment regimen with the decision to use antibiotics. Probiotics have long been known to have beneficial effects on the digestive system. Not only limited to the gastrointestinal tract but probiotics are also known for their role in reducing infections in the respiratory system. Recently, the investigators have successfully conducted a clinical trial of nasal-spray Bacillus spore probiotics in children infected with respiratory syncytial virus (RSV), and the data show that the probiotics can rapidly and effectively relieve symptoms of RSV-induced ARTIs while exhibiting strong impacts in reducing viral load and inflammation. Here, the investigators conducted a study that directly spraying probiotics into the nose can effectively support to treatment of both ARS and AOM. The aim of the study about to evaluate the safety and effectiveness of nasal-spraying probiotics containing spores of Bacillus subtilis and Bacillus clausii in the supportive treatment of patients with ARS and AOM. Study Population: sample size is 120. Description of Sites: the study is carried out at Thai Binh Medical University Hospital and Thai Binh Children's Hospital. Description of Study Intervention: 120 eligible patients are divided into 2 groups (n=60/group) including the ARS group and the ARS accompanied by the AOM (ARS & AOM) group. 60 patients in each of the above groups were randomly assigned to two subgroups (n=30/subgroup): Patients in the Control-ARS and Control-ARS & AOM subgroups received the routine treatment and three times per day nasal-spraying 0.9% NaCl physiological saline. In contrast, the patients in the Navax-ARS and Navax-ARS & AOM subgroups received three times per day nasal-spraying LiveSpo Navax® in addition to the same standard of care treatment. The standard treatment regimen is 3-7 days, depending on the severity of the disease when the patient arrives for the exam and the progression of the disease during the treatment period. Study duration: 18 months
Mepolizumab is a biologic agent already approved for severe asthma. Recently, there is increasing evidence concerning the benefit of anti-IL5 treatments upon patients with nasal polyposis with or without severe asthma. The novelty of this project is that no biologic agent has yet been fully investigated to identify any biomarkers of response for patients with nasal polyps with or without asthma including sinonasal tissue remodeling a key element in the resultant histopathological changes of the inflammation. The investigation of airway remodeling of various locations (nose and bronchus) under mepolizumab treatment will be our primary objective on the long-term basis of 156 weeks of treatment. Endobronchial and nasal biopsies will be performed as routine care for tissue evauation and disease investigation for every patient. Besides, the united airways will provide better guidance for medical treatment of chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) and asthma. The initial idea is based on investigating the characteristics that could predict the effectiveness of mepolizumab on patients with nasal polyposis with or without asthma. Patients will receive 39 doses of mepolizumab for 156 weeks. An additional aim of this study is to identify characteristics of non-responders and responders to mepolizumab. Responders will be identified based on airway remodeling status, biomarkers in tissue and secretion samples and on the reduction of the need of surgery through Lund-Kennedy endoscopic score, Lund-Mackay score and patient's clinical status in the 6th, 12th and 36th month after the initiation of treatment. Regarding the unified airway system, nose and pharyngeal microbiome will be evaluated before and after 52 weeks of mepolizumab treatment in patients with nasal polyps whereas in patients with nasal polyps and asthma bronchus microbiome will also be evaluated. Lung samples will help gain information about the inflammatory profile and local microbiome of CRSwNP patients with asthma through molecular and cellular assays. The human Pharyngeal Microbiome might play a protective role in Respiratory Tract Infections and it has been reported that the microbiome provides critical signals to promote maturation of immune cells and differentiation of the tissue. Thus, we will make an effort to correlate microbiome of various locations with clinical and laboratory characteristics of responders and non-responders to mepolizumab treatment.
This study aims to analyze the immune profiles of patients with Chronic Rhinosinusitis with Nasal polyps (CRSwNP) with and without asthma before and after Mepolizumab. A group of participants with CRS without nasal polyps (CRSsNP) with asthma will be included to compare their immune profiles to CRSwNP.
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
Multicenter, phase III, randomized, blinded, controlled, parallel group.
The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP
The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months). The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.
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.
The goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (CRSwNP), such that specific molecular markers of inflammation can be identified.
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).