Clinical Research Directory

ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia

ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).

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

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

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma

This study is a randomized, double-Blind, placebo-controlled, Single and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma.

A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common condition causing nasal congestion, discharge, and reduced sense of smell, seriously affecting patients' quality of life. A subtype called eosinophilic CRSwNP (eCRSwNP) is difficult to treat and often recurs after surgery. Currently, diagnosing this subtype requires tissue samples after surgery, which delays treatment decisions and may lead to unnecessary surgeries. Our research team has developed a new, non-invasive diagnostic system using advanced spectral technology to detect a natural fluorescence marker inside eosinophils (a type of immune cell) in nasal polyps. This system can quickly identify eCRSwNP before surgery by shining a safe light on the nasal tissue and analyzing the fluorescence signals. This study aims to evaluate how accurate and safe this real-time diagnostic system is in clinical practice. If successful, it will help doctors choose better personalized treatments, reduce unnecessary surgeries, lower recurrence rates, and ultimately improve patients' lives.

Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps

TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP

This study compares two surgical approaches combined with anti-IL-5 therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Patients will be randomly assigned to one of the three groups: (1) anti-IL-5 alone, (2) anti-IL-5 with simple polyp removal, or (3) anti-IL-5 with extended sinus surgery. The aim of this study is to see if a less invasive surgery (simple polyp removal) with anti-IL-5 works as well as more extensive surgery with anti-IL-5. Participants will be followed for 1 to 3 years.

Implementation of a Joint Pulmonologist and ENT Consultation in the Care Pathway of Patients Suffering From Asthma and Chronic Rhinosinusitis With Nasal Polyposis: Effectiveness Compared With Consultations by Specialty (CON-PO Study).

Asthma affects the lower respiratory tract (bronchi), whereas chronic rhinosinusitis with nasal polyposis (CRSwNP) involves the upper airways. Despite this anatomical distinction, the upper and lower airways form a continuous respiratory tract and share common pathophysiological mechanisms. Consequently, asthma and CRSwNP frequently coexist, and several therapeutic strategies are effective for both conditions. Given these overlaps, we hypothesize that a multidisciplinary consultation involving both a pulmonologist and an ENT specialist could be more effective than separate consultations for patient care. We also believe that this innovative organization that would benefit the healthcare system. To test this hypothesis, we are conducting a study whose primary objective is to assess whether joint consultations lead to a reduction in oral corticosteroid need over the year following the initial consultation, by enabling more personalized treatment strategies. Secondary outcomes will include the frequency of asthma exacerbations, frequency of ENT-related events, respiratory symptoms, quality of life, and healthcare ressources utilization. We will compare outcomes between two patient groups: one receiving joint consultation from both specialists, and the other managed through standard, separate consultations as per current clinical practice.

Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps

In this study, we will investigate the effect of tezepelumab on the epithelial barrier function of the upper and lower airways in patients suffering from severe asthma with and without chronic rhinosinusitis with nasal polyps. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens) in cultured primary respiratory tract epithelial cells. Furthermore we will assess changes in clinical parameters, cellular composition and inflammatory mediators.

International Severe CRSwNP Registry 2024-2028

The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".

Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are: * Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD? * Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS? Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.

Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

The goal of this observational study is to learn more about the real-world efficacy of biologics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). All patients who are 18 years or older, who have CRSwNP and are eligible for reimbursement of a biological for the indication of CRSwNP can be included. The main question is the efficacy of biologics in real life after 24 weeks. The main focus are patient reported outcomes measured via several questionnaires and the nasal polyp score, scored with nasal endoscopy.

Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

Nasal microorganisms, exfoliated cells, nasal secretions, fetal microorganisms and blood were collected from patients with chronic sinusitis with nasal polyps before medication. Nasal polyp tissues of the patients were clamped for pathologic biopsy in the outpatient clinic. Methylprednisolone was then administered to the patients for 17 days, and the nasal microbial changes were observed after the administration of the drug. Patients underwent surgical treatment after the administration of the drug, and postoperative patients were followed up for a long period of time until polyp recurrence. During the follow-up, the microorganisms in the patients' postoperative nasal cavities were collected and the postoperative microbial changes were recorded