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Sinusitis clinical trials

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NCT ID: NCT06461949 Recruiting - Asthma Clinical Trials

Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray

Start date: June 26, 2024
Phase: Phase 3
Study type: Interventional

Background: Allergic fungal rhinosinusitis (AFRS) is a severe type of sinus infection. People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing. Surgery can remove the polyps, but they often grow back. Researchers want to test an approved drug they believe may help people with AFRS. Objective: To test a drug (Dupilumab) in people with AFRS. Eligibility: People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps. Design: Participants will have several tests before their surgery. They will have imaging scans of their sinuses. They will have an endoscopic exam: A tube with a camera and a light will be inserted into their sinuses. They may give blood and mucus samples. They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery. Excess nasal tissue removed during the surgery will be collected for research. Then they will begin treatment with the study drug. Dupilumab is injected under the skin. Some participants will receive the study drug. Some will receive a placebo injections. The placebo injections are just like the study drug but contain no medicine. Participants will not know which injections they are getting. All participants will administer the injections to themselves at home. They will do this every 2 weeks for 1 year after the surgery. They will have a clinic visit 16 weeks after surgery. Participants will have follow-up for 12 weeks after treatment ends.

NCT ID: NCT06398873 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP

EpiBar
Start date: June 6, 2024
Phase:
Study type: Observational

The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.

NCT ID: NCT06393946 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyposis

Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France

OPALE
Start date: October 20, 2023
Phase:
Study type: Observational

This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities. As well as to assess the clinical outcome after initiation of dupilumab (Dupixent®) and safety of the product during the two years of treatment

NCT ID: NCT06338995 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Start date: April 29, 2024
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

NCT ID: NCT06272123 Recruiting - Chronic Sinusitis Clinical Trials

Endotypic Stability in CRS

Start date: January 1, 2024
Phase:
Study type: Observational

A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients

NCT ID: NCT06264141 Recruiting - Clinical trials for Recurrent Acute Rhinosinusitis

Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis

NONS-RARS-01
Start date: January 16, 2024
Phase: Phase 2
Study type: Interventional

A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy.

NCT ID: NCT06198894 Recruiting - Chronic Sinusitis Clinical Trials

Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Start date: January 10, 2024
Phase: N/A
Study type: Interventional

Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms

NCT ID: NCT06164704 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps

VIBRANT
Start date: December 18, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal polyps in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo.

NCT ID: NCT06130176 Recruiting - Maxillary Sinusitis Clinical Trials

Single-step Functional Sinus Endoscopy and Transoral Surgery

Start date: November 11, 2018
Phase: N/A
Study type: Interventional

Dento- alveolar or dental structural diseases that affect the floor of the maxillary sinus can cause maxillary sinusitis which is known as odontogenic maxillary sinusitis (OMS). Many treatment protocols have been documented to treat OMS. However, There is no unanimity among clinicians on how and who should treat OMS, whether is it otolaryngologist, oral/maxillofacial surgeons, or dentist. Therefore, this study will be will be enrolled to evaluate the efficacy of the Single-step Functional Sinus endoscopy and trans-oral surgery in the management of maxillary sinusitis raised from Odontogenic origin via Department- integrated therapy.

NCT ID: NCT06129552 Recruiting - Allergic Rhinitis Clinical Trials

Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps

Start date: December 19, 2023
Phase:
Study type: Observational [Patient Registry]

During this project, the investigators want to explore in vitro changes in basal cells and the crosstalk with residing immune cells as potential pathogenic mechanisms in CRSwNP vs healthy controls by using surgically resected patient samples.