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Nasal Polyps clinical trials

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NCT ID: NCT05365841 Recruiting - Clinical trials for Severe Eosinophilic Asthma w/wo CRSwNP

Role of Epithelial Barrier Integrity in Biologic Treatment Response of Severe Asthmatics With/Out Chronic Rhinosinusitis With Nasal Polyps (CRSwNP).

Start date: May 15, 2022
Phase:
Study type: Observational

Advances in understanding the pathophysiology of asthma development and severity have pointed towards a prominent role of the bronchial epithelium, especially in more chronic and severe disease. Studies suggest that airway eosinophilic inflammation in asthma is linked to epithelial injury and structural changes of the airways, co called airway wall remodeling. Together the chronic airway inflammation and remodeling are associated with bronchial hyperresponsiveness, fixed airflow obstruction or progressive loss of lung function and clinical severity of asthma. Chronic rhinosinusitis with nasal polyps (CRSwNP), is another respiratory inflammatory disease often co-existing with severe asthma, sharing similar pathophysiology. The investigators hypothesize that epithelial barrier integrity may play a role in the pathophysiology of severe eosinophilic asthma and nasal polyposis and in response to anti-IL5 therapy of severe asthmatics, and that shedding of epithelial barrier proteins may be used as biomarker in the management of severe asthma. In order to study that, the investigators will conduct a prospective cohort study of adult severe asthmatics with/out CRSwNP, who live on the island of Crete, Greece and who meet the criteria for entering anti-IL5 treatment, as assessed by pulmonologist. The participants will be recruited with a convenience sampling in a period of 2 years, under real life conditions, and will be followed up for 1 year after treatment initiation. A control group of subjects diagnosed with nasal polyposis without severe asthma will be used. Eligible subjects will undergo clinical assessment with radiological (CT) and endoscopic investigations. Samples of serum, sputum, nasal secretions, as well as nasal and bronchial biopsies will be obtain for assessing clinicopathological differences among the 3 groups but also response to anti-IL5 therapy in SEA w/o CRSwNP.

NCT ID: NCT05355207 Not yet recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Study to Evaluate Safety and Activity of TRL1068 in Chronic Rhinosinusitis

Start date: January 2024
Phase: Phase 1
Study type: Interventional

TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens. This initial study is to assess overall safety and pharmacokinetics (PK) of TRL1068. The goal of the development program is to demonstrate effectiveness of TRL1068 in difficult to treat bacterial infections such as in CRS.

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: NCT05287841 Recruiting - Allergic Rhinitis Clinical Trials

Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.

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.

NCT ID: NCT05248997 Completed - Clinical trials for Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Start date: February 17, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.

NCT ID: NCT05246267 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

Start date: February 15, 2022
Phase:
Study type: Observational

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

NCT ID: NCT05228041 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

BIOlogics in Severe Nasal POlyposis SurvEy

BIOPOSE
Start date: February 10, 2022
Phase:
Study type: Observational

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production. New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. Herein we propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.

NCT ID: NCT05180357 Completed - Nasal Polyps Clinical Trials

RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

RANS
Start date: November 23, 2021
Phase:
Study type: Observational

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.