View clinical trials related to Nasal Polyps.
Filter by:The goal of this observational study is to learn about the agreement between sensors analyzing algorithm and body plethysmography in measuring oral and nasal breathing in healthy adults, and in patients with chronic rhinosinusitis, asthma and chronic obstructive pulmonary disease. The main question it aims to answer is: • Is the algorithm-based method accurate enough in analyzing respiratory obstruction as compared to body plethysmography (reference method)? Participants will perform a short breathing protocol (oral and nasal breathing with different masks) during which time their breathing is monitored with both methods.
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
The purpose of this study is to investigate the relationship between long-term use of systemic steroids in patients with upper and lower respiratory tract diseases and their own production of cortisol (cross-sectional), as well as whether those with low cortisol levels have an impact on bone density. As patients with CRSwNP have a high use of steroids, they routinely undergo a DEXA scan at the Respiratory Clinic, Department of Ear-Nose-Throat Surgery and Audiology (ENT) - Rigshospitalet (RH) to examine whether their bone density and structure are affected. The scan will be included as a clinical secondary outcome to assess whether systemic steroid use has an impact on this. The purpose of the study is therefore to compare steroid intake, baseline P-cortisol, the body's response to ACTH (measured by cortisol levels after the test), and bone density in patients with chronic sinusitis (CRS) with and without asthma in an unselected population at the Respiratory Clinic (cross-sectional). In addition, at the 4-month follow-up (exploratory follow-up, pilot project), it will be investigated whether good adherence (>80%) to inhalation therapy (nasal steroid and lung steroid) and additional treatment with biologicals has a negative effect on the body's own production of P-cortisol.
Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.
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.
The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant effector pathways that lead to clinical benefit.
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).
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.
This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.
This clinical trial will compare treatment in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma. The patients will be randomized to treatment with the biologic drug, Mepolizumab, or the biologic drug Mepolizumab combined with Functional Endoscopic Sinus Surgery (FESS). The aim of this study is to evaluate the effect of combined treatment with biologic treatment and surgery vs. biologic treatment only. The hypothesis is that surgical removal of polyps and inflamed tissue from the nasal sinuses will increase the effect of the biologic treatment, leading to a lower disease burden after 6 months of treatment, compared with biologic drugs only. Furthermore, combined biologics and surgery will keep a lower disease burden and better general health after 12 months of treatment than biologics alone. Inclusion criteria: - Patients ≥ 18 years old at the time of signed informed consent (no upper limit) - Patients who are referred to the outpatient clinic for the following reasons: - Doctor's diagnosis of CRS - NPS ≥ 2+2 out of a score of 8 (max) - Severity measured as an SNOT22 score > 35 - One FESS in general anaesthesia performed prior to inclusion (no time limitations) - No course of systemic steroids within the last 3 months, whereas a daily low dose is allowed - Possible doctor's diagnosis of asthma - Type 2 inflammation Exclusion criteria: - Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires - Patients who currently receive biologics for any other disease - Patients who have previously or currently received biologics for CRS or asthma - Patients who are not able to give informed consent (i.e., patients who are permanently incapable) - Patients who meet ≥1 of the following: - Malignant lung disease - Cardiac disease of clinical importance - Current pregnancy and breastfeeding, as well as planning to be pregnant in the near future - Unwillingness to have FESS performed - Patients needing FESS or systemic steroids (OCS) during the study period will be excluded after an unscheduled visit (last observation carried forward (LOCF)) - Patients who are not eligible because of the investigator's judgement The effect of the treatment will be evaluated with objective procedures and questionnaires related to CRSwNP and asthma after 3, 6 and 12 months.