View clinical trials related to Nasal Polyps.
Filter by:The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients. The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of: - A subjective score (the SNOT-22) - An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8)) Methods: Participants will be randomized into two groups and receive either drug in the standard dose. After 24 weeks the effect is assessed. If the clinical effect is sufficient in terms of the criteria set by the Danish Medicinal Council (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment. All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include different questionnaires and nasal endoscopy. This trial includes three treatment arms. 1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach. The presence of adverse effects will be assessed in each treatment arm.
The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline. However, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated. The investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects: i) Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.
The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are: 1. To see what mepolizumab does to suppress inflammation of the human cells. 2. To see what mepolizumab does to maintain barrier integrity of epithelial cells
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.
It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP. Participants will receive AIRIVER Nasal drug-coated balloon treatment.
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.
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Patients will receive GR1802 injection or Placebo every 2 Weeks.