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Nasal Polyps clinical trials

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NCT ID: NCT06118554 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

3D Printing to Improve Nasal Irrigation Outcome

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

Three-dimensional (3D) printing has been an emerging technology with uses in a wide array of fields. This research aims to use 3D printing as a tool to provide personalized education to maximize treatment efficacy based on the patient's individual anatomy. With increased irrigation to the sinuses, we hypothesize there will be improved patient satisfaction and higher quality of life. The outcomes of this research could lead to a new option for patients who live with chronic rhinosinusitis are not candidates for surgery or are interested in less invasive options. The 3D printed nasal replica is not something that would be implanted, rather it is a hand-held device used specifically for participants to better understand their nasal anatomy.

NCT ID: NCT05891483 Active, not 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: NCT05878093 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Dupilumab in Chinese Adult Participants With CRSwNP

Start date: May 16, 2023
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05865496 Active, not recruiting - Sinusitis Clinical Trials

A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Start date: June 30, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

NCT ID: NCT05649813 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region

Start date: November 20, 2022
Phase:
Study type: Observational [Patient Registry]

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).

NCT ID: NCT05553951 Active, not recruiting - Asthma Clinical Trials

Adherence in Global Airways

AIR2022
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

There is a strong case for treating diseases of both the upper and lower airways (global airways) simultaneously because they share the same inflammatory mechanisms. About 9% have chronic sinusitis (CRS) and 4% of the Danish population are diagnosed with CRS with nasal polyps (CRSwNP)) and 7-10% have asthma. CRS has a multifactorial background, with CRSwNP characterized by Type 2 inflammation, and approximately 50% with Type 2 CRSwNP also have co-morbid asthma. Well-treated CRS has an impact on asthma control, and well-treated asthma has an impact on CRS. Several studies show that patients with asthma have low adherence, but only a few if any of studies are available on adherence in CRS. Aim: To investigate the effect of systematic and structured nursing supervision in patients with CRSwNP and asthma primarily on adherence. Hypothesis and research questions: Patients with respiratory diseases can improve their adherence to their non-medical and medical treatment for CRSwNP/CRS and asthma by systematic and structured nursing supervision compared to patients who receive usual care. In a randomized clinical trial, we will investigate whether the level of adherence measured by the questionnaire MARS-5-N and MARS-5- L in patients with CRSwNP and asthma can be improved by 7 points after systematic and structured nursing guidance at baseline visit and controlled after four months - compared with those patients who have not received the above guidance. Primary outcome: is change in adherence rate measured by the MARS-5-N/L questionnaire in patients with CRSwNP and asthma can be improved by 4 points after systematic and structured nursing guidance at the initial visit and controlled after four months - compared with patients who have not received the above guidance. Inclusion Criteria: Adherence to MARS- 5 L/N ≤35 at first visit, diagnosed with asthma (with/without allergic rhinitis) at initial visit, diagnosed with CRSwNP, able to use smartphone, ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma), >18 years of age, SNOT-22 score ≥35 Exclusion Criteria: - Adherence to MARS-5- L/N >35 points at first visit,do not have smartphone, does not read/speak English, other illness requiring regular medication, pregnancy/pregnancy that started during the study, server psychological comorbidities Questionnaires: Patients must answer the following questionnaires at baseline and at 4 months follow up ESS, SNOT-22, ACQ-7, ACT, MiniAqLq, HADS, STARR-15

NCT ID: NCT05529784 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)

DUPIREAL
Start date: October 6, 2021
Phase:
Study type: Observational

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling. So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series. Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting. The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS). The secondary objectives are: - the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction - the assessment of the patients' quality of life - the recording of major and minor complications - the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021 - the assessment of efficacy based on concomitant disease (Asthma and ASA triad) - the evaluation of potential predictors of clinical response to the therapy

NCT ID: NCT05324137 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

DUBHE
Start date: July 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.

NCT ID: NCT05281523 Active, not recruiting - Nasal Polyps Clinical Trials

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

ANCHOR-2
Start date: April 18, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.

NCT ID: NCT05274750 Active, not recruiting - Nasal Polyps Clinical Trials

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

ANCHOR-1
Start date: April 22, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.