Nasal Polyp

Researchers are investigating the use of three-dimensional 3D printing technology to improve nasal irrigation outcomes for adults with chronic rhinosinusitis, with or without nasal polyps. Chronic rhinosinusitis is a common condition causing nasal obstruction, facial pain, nasal discharge, and loss of smell, significantly affecting quality of life. This study aims to personalize nasal irrigation techniques based on individual nasal anatomy to enhance treatment effectiveness and patient satisfaction, especially for those who are not candidates for surgery or prefer less invasive options. Participants use a 3D-printed nasal replica derived from their CT scans to help determine the best head position for nasal irrigation. The study compares three groups a control group using the standard FDA-recommended head position, a backfill group using a specific 90-degree ear-to-shoulder tilt, and a model group using a personalized optimal position based on their 3D nasal replica. All participants irrigate their sinuses once daily with 2 mg mometasone in 240 mL NeilMed sinus rinse bottles for 8 weeks. During the study, participants complete symptom evaluations including the Nasal Obstruction Symptom Evaluation NOSE score, 22-item Sino-Nasal Outcome Test SNOT-22, and Visual Analogue Scale VAS for nasal congestion at baseline and after 8 weeks of treatment. CT scans assess sinus inflammation using the Lund-Mackay LM score at the same time points. The study monitors patient adherence and collects data to evaluate whether personalized irrigation improves quality of life and nasal symptom relief over the 8-week treatment period.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of VVN432 Nasal Spray in both healthy adults and patients with chronic rhinosinusitis CRS. This clinical study has two parts Phase 1a focuses on healthy volunteers to assess safety and drug behavior, while Phase 1b involves patients with CRS to also evaluate preliminary efficacy. The trial includes adults aged 18 to 55 years and aims to better understand how this nasal spray works and its safety profile in these groups. The study tests different doses and regimens of VVN432 Nasal Spray, including single and multiple doses. In Phase 1a, healthy subjects receive single doses of 0.5% or 1% spray, one or two sprays per nostril, or placebo. In Phase 1b, patients use the nasal spray twice daily for 28 days, with similar dosing groups and placebo controls. Both phases are randomized, double-masked, and vehicle-controlled to compare effects accurately. Participants will undergo regular safety and tolerability assessments from baseline to Day 10 for Phase 1a and to Day 35 for Phase 1b. Pharmacokinetic measurements of VVN432 will be taken at various time points to monitor drug levels locally and systemically. Patients with CRS will also have symptom scores recorded to evaluate nasal congestion and overall symptoms. The total participation time varies by study part, with detailed monitoring to ensure participant safety and collect important data on the nasal sprays effects.

Researchers are evaluating BBT002, a drug being studied for its safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity in healthy volunteers and people with Chronic Rhinosinusitis with Nasal Polyps CRSwNP, with or without asthma. This randomized, double-blind, placebo-controlled study includes participants from 18 to 75 years old and aims to understand how BBT002 behaves in the body and its effects on these conditions. The study has two parts Part A involves a single dose of BBT002 or placebo given to healthy volunteers in increasing dose groups. Part B includes patients with CRSwNP, with or without asthma, who receive five repeated doses of BBT002 or placebo. The doses are given sequentially, and the study monitors participants for safety and drug activity over time. Participants will undergo various assessments including monitoring for adverse events, vital signs, physical exams, laboratory tests, and ECG readings up to 141 days after a single dose in healthy volunteers and up to 169 days after the first dose in patients. Researchers will also measure how the drug is processed in the body and check for immune responses. The total study duration extends until June 2028, ensuring comprehensive evaluation throughout the treatment and follow-up periods.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are studying chronic rhinosinusitis with nasal polyps CRSwNP in Chinese adults to assess nasal polyps score and symptom changes after starting treatment with tezepelumab. This Phase 3b, open-label, single-arm study focuses on participants with an eosinophilic type of CRSwNP, as defined by a specific JESREC score. About 230 participants will be enrolled from multiple sites across China to evaluate this treatments impact on their condition. Eligible participants will receive a fixed dose of tezepelumab 210 mg administered subcutaneously every four weeks for up to 24 weeks, totaling six doses. All doses will be given at the study sites. This study uses a single group design where all participants receive the same treatment, aiming to observe changes over time without a comparison group. Participants will be involved for about 24 weeks during which researchers will assess nasal polyp scores and nasal congestion changes from baseline to the end of treatment. They will also monitor symptom improvements using various patient-reported measures and clinical tests at multiple time points throughout the study. Safety and response to treatment will be carefully tracked to understand tezepelumabs effects on nasal polyps and related symptoms.

Researchers are conducting a prospective, multicenter real-world study to observe the postoperative outcomes, quality of life, disease control, patient characteristics, economic burden, and treatment patterns in Chinese patients with Chronic Rhinosinusitis with Nasal Polyps CRSwNP who have undergone surgery. The study focuses on patients who have experienced recurrence and aims to provide a detailed understanding of their clinical trajectory and well-being after surgery. Participants will undergo a standard surgical procedure called Functional Endoscopic Sinus Surgery FESS as part of routine clinical care. This procedure is not experimental and will be performed according to local guidelines and the treating physicians discretion. The study will follow participants for 52 weeks after surgery, monitoring various clinical outcomes through scheduled assessments. Throughout the study, participants will receive standard medical care as determined by their physicians and attend scheduled clinical evaluations. Researchers will collect data on symptom scores, nasal polyp assessments, CT imaging, quality of life measures, medication use, and recurrence rates. The study aims to track changes in these measures from baseline up to 52 weeks post-surgery to better understand patient recovery and disease management over time.

Nasal sinus polyposis is a chronic inflammatory condition affecting the nasal cavity and sinuses, leading to multiple bilateral polyps. This condition affects 2 to 4% of the general population and is challenging to manage because current treatments often fail or lead to symptom recurrence. Researchers are studying the anatomical, clinical, and biological profiles of patients with severe nasal polyps to better predict how patients will respond to surgery and biotherapy treatments. The study involves identifying anatomo-clinico-biological correlations by examining the anatomopathological profile, clinical features, and cytokine signatures of nasal polyps. These profiles aim to guide patient management, especially for those resistant to medical treatments and requiring first-time surgical treatment such as ethmoidectomy. The research assesses these factors to help predict treatment response, including to newer biologic therapies. Participants will undergo evaluations including anatomical profiling, symptom assessment using a visual analogue scale, quality of life measurement with the Sino-Nasal Outcome Test, biological profiling, and cytokine concentration analysis in serum. These assessments occur on a single day. The study monitors symptom severity, quality of life, and biological markers to understand treatment resistance. Participation involves a one-day visit for these detailed evaluations under medical supervision.

This clinical trial evaluates the use of Artificial Intelligence AI to analyze endosseous lesions in patients with maxillary or mandibular cysts. Traditional interpretation of cone beam computed tomography CBCT scans relies on qualitative and experience-dependent methods, which may underestimate lesion complexity. The study aims to compare AI-based segmentation and volumetric analysis with conventional CBCT interpretation to assess potential improvements in lesion evaluation and clinical outcomes. Participants will be randomly assigned to either receive conventional CBCT evaluation or AI-assisted evaluation of their scans. The AI tool performs automated segmentation of the lesion, 3D reconstruction, and volumetric calculation to provide objective and reproducible measurements. This approach seeks to enhance surgical planning, predict anatomical involvement, reduce diagnostic errors, and standardize follow-up assessments. During the study, researchers will measure the time required for CBCT interpretation and monitor intraoperative and postoperative complications. Participants will undergo evaluations on day 1, including scan analysis and clinical assessments. The study involves adults aged 18 to 80 years in good health, with no contraindications for surgery, and will continue until May 2026.

Researchers are evaluating four different isotonic and hypertonic seawater-based nasal sprays in real-life settings for their effectiveness, safety, usage, tolerance, and user satisfaction. The study focuses on infants, children, adults, and pregnant or breastfeeding women who have acute or chronic sinonasal conditions such as upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis, bronchiolitis, COVID-19, and post-surgery nasal issues. The investigation aims to understand how these devices perform when used as intended across various patient groups. Participants will use one of four CE-marked nasal spray devices according to their specific indications and target populations. The sprays include Respimer Hygiene-Prevention for babies, kids, and adults, Respimer Decongestion for babies from two months old and older, and Phytosun arms Hypertonic nasal wash for children six years and older and adults. Usage instructions vary by product, ranging from 1 to 6 sprays per nostril daily, with different frequencies for treatment and prevention purposes. The study period covers up to three months to assess both short-term and longer-term effects. During the study, participants or their parents will complete online questionnaires and follow healthcare providers advice on nasal wash techniques. Researchers will monitor nasal symptom changes, including intensity and frequency, improvement in nasal breathing, quality of life, and satisfaction with the sprays. Effectiveness will be evaluated from day 0 to day 5 for acute conditions and up to day 14 for chronic issues, extending to three months for seasonal symptom management. Safety, tolerance, and usage patterns will also be recorded throughout the study.

Researchers are studying chronic rhinosinusitis with nasal polyps CRSwNP and allergic rhinitis by examining differences in basal and epithelial cells from patient and healthy control samples. They aim to understand cell functions, gene expression, and immune cell interactions that may contribute to these conditions. The study also includes an allergic rhinitis subset to explore whether changes are specific to CRSwNP or common in type 2 inflammatory diseases of the upper airways. The study collects tissue samples through surgical procedures such as conchotomy, aesthetic nose surgery, or functional endoscopic sinus surgery. These samples will be analyzed in the laboratory to investigate basal cell activation, genetic imprinting, secreted proteins, and interactions with regulatory T cells. Different sequencing techniques and co-culture experiments will be used to compare cells from CRSwNP patients, allergic rhinitis patients, and healthy controls. Participants will provide tissue samples during surgery, and researchers will perform functional assays, gene expression profiling, and co-culture studies over 9 to 24 months. The study will measure functional differences between cell types, gene expression patterns, and immune cell interactions. The goal is to better understand the underlying mechanisms of CRSwNP and related conditions to inform future research. Participation involves sample collection during surgery and follow-up laboratory analysis without ongoing treatment or intervention.