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Sinusitis clinical trials

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NCT ID: NCT05891483 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

Start date: September 4, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05883462 Recruiting - Clinical trials for Chronic Rhinosinusitis

Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)

Start date: June 7, 2023
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT05882903 Recruiting - Clinical trials for Chronic Rhinosinusitis (Diagnosis)

The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)

Start date: August 17, 2023
Phase: Phase 2
Study type: Interventional

To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.

NCT ID: NCT05873803 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

The Study of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Start date: February 8, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05857228 Recruiting - Clinical trials for Chronic Rhinosinusitis (Diagnosis)

Viral and Epigenetic Influences in CRSwNP

Start date: May 18, 2023
Phase:
Study type: Observational

Background/rationale While multiple disorders feature a Type 2 (T2) inflammation, triggers for T2 remains unknown. In Chronic Rhinosinusitis with Nasal Polyposis CRSwNP), a classic Type 2 disorder, dysfunction of the epithelial barrier is suggested by loss of epithelial cell differentiation, impaired response to wounding, and impairment of innate defense mechanisms. After unsuccessful attempts to describe T2 disorders solely by host genetic or environmental factors, the role of epigenetics in the modification of innate immune response and epithelial integrity appears an important unexplored mechanism for a novel appreciation of T2 disease. In addition, the investigators explore the possibility that these changes may be induced by viral pathogens. This concept has been supported by the recent observation that SARS-CoV-2 viral reduction measures resulted in a reduction of the frequency of respiratory viruses and a concomitant reduction in chronic airway disease, suggesting a role for viruses in T2 disease. Hypothesis The investigators believe T2 chronic rhinosinusitis (CRSwNP) involves epigenetic mechanisms where external factors, possibly viruses, contribute to disease via epigenetic manipulation and/or chronic viral infection. Objectives The investigators aim to identify epigenetic signatures associated with T2 CRS and explore the contribution of viruses. Method A robust methylation profiling with extensive coverage will be used for epigenome-wide association studies in T2 CRS patients assessing healthy subjects, CRS patients in remission, and diseased patients undergoing surgery. Moreover, advanced transcriptomic and metagenomic methods will identify gene expression profiles and viruses. This proposal also includes a cross-sectional study of patients undergoing surgery to assess transcriptomic patterns and epigenetics at the single-cell level. Expected outcome The investigators expect to identify epigenetic biomarkers and implicate several pathogenic viruses to open new targets for novel therapies.

NCT ID: NCT05843019 Recruiting - Asthma Clinical Trials

Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis

AGAS 2023
Start date: April 12, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05757479 Recruiting - Clinical trials for Radiation-Induced Mucositis

Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis

Start date: February 11, 2023
Phase: Phase 3
Study type: Interventional

Sinusitis is one of the most common sequelae after radiotherapy among nasopharyngeal carcinoma patients. While local steroids have been shown to be effective in the management of patients with chronic rhinosinusitis, their role in treating radiation-related sinusitis is ambiguous. Poor adherence to nasal steroid spray often contributes to the failure of symptom relief. The aim of this study is to determine if steroids stents implantation into the sinuses could improve patient outcomes in radiation-related sinusitis.

NCT ID: NCT05642806 Recruiting - Asthma Clinical Trials

Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment

Start date: July 1, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05626257 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps

Start date: January 12, 2023
Phase:
Study type: Observational

This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.

NCT ID: NCT05598424 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps

Start date: November 22, 2022
Phase: Phase 4
Study type: Interventional

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 level in nasal secretions. The goal of this single-arm clinical trial based on a multicenter platform is to test CST1 in patients with chronic rhinosinusitis and nasal polyps before and after oral glucocorticoid therapy. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score and other biomarkers are also evaluated before and after the treatment. Researchers will develop a CST1 predictive model of oral glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.