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 spray's effects.

This research aims to evaluate the effectiveness and safety of lebrikizumab in people with chronic rhinosinusitis and nasal polyps who are also treated with intranasal corticosteroids. The study is a Phase 3 clinical trial lasting about 18 months and includes participants aged 12 years and older. It is designed to understand how lebrikizumab works alongside standard nasal spray treatment for this condition. Participants will receive lebrikizumab through subcutaneous injections every 2, 4, or 8 weeks, depending on the assigned group. All participants continue using their regular intranasal corticosteroid sprays during the study. Adolescents aged 12 to under 18 years will receive open-label lebrikizumab injections every 2 or 4 weeks. There is also a placebo group receiving injections without the active drug but with the same nasal spray background treatment. During the study, participants will be monitored regularly for changes in nasal congestion and nasal polyp size over 24 weeks, using participant reports and endoscopic examinations. Other assessments include sinus imaging, lung function tests, smell loss severity, postnasal drip symptoms, and quality of life questionnaires. Safety and adherence will be closely observed throughout the 18-month study period to ensure participant well-being.

Researchers are evaluating the effects of tezepelumab treatment in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have been determined by their physician to be eligible for surgery. This phase IIIb, multicenter, open-label, single-arm study aims to describe changes in nasal congestion and overall sino-nasal symptoms after starting tezepelumab. The study includes participants with or without asthma and focuses on symptom improvements using patient-reported measures. Participants will receive a single dose of tezepelumab via subcutaneous injection every four weeks for up to 24 weeks. The study is organized into three periods: a screening period lasting up to four weeks before treatment begins, a 24-week treatment phase, and a 12-week safety follow-up period after treatment ends. Approximately 60 sites across 10 countries will enroll adults with surgery-eligible CRSwNP. During the study, participants will attend visits every four weeks for assessments, including symptom scores like nasal congestion and sino-nasal outcome tests. Researchers will monitor changes from baseline in these symptoms at multiple time points, along with other measures such as loss of smell, sleep quality, and nasal obstruction. Safety follow-up will continue for 12 weeks after treatment, allowing researchers to evaluate treatment outcomes and participant well-being throughout the study period, which lasts up to 40 weeks in total.

Researchers are evaluating the nasal polyps score and symptoms in Chinese adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) who begin treatment with tezepelumab. This Phase 3b, multicentre, open-label, single-arm study includes about 230 adults who have an eosinophilic type of this disease, defined by a JESREC score of 11 or higher, with about 30% having an even higher score of 15 or more. The study is sponsored by AstraZeneca and is designed to better understand how tezepelumab affects nasal polyps and related symptoms over time. Eligible participants will receive a fixed dose of 210 mg tezepelumab given as a subcutaneous injection every four weeks for 24 weeks, totaling six doses. All doses will be administered at the study sites. Since this is a single-arm study, all participants receive the same treatment without comparison to a placebo or other drug. The study specifically includes participants who have severe nasal polyps requiring surgery and ongoing symptoms despite standard treatments like intranasal corticosteroids. Participants will be closely monitored throughout the study from baseline to week 24. Researchers will assess changes in nasal polyp scores, nasal congestion, sino-nasal symptoms, sleep quality, sense of smell, and lung function for those with asthma. These assessments include patient questionnaires, nasal polyp scoring by central readers, peak nasal inspiratory flow measurements, and monitoring of exacerbations. The study also involves safety monitoring and will document participant responses over the treatment period to better understand tezepelumab's effects on CRSwNP symptoms and disease control.

This research aims to describe postoperative outcomes, quality of life, disease control, and characteristics of Chinese patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have undergone surgery. It also evaluates the economic burden and post-operative treatment patterns in patients with recurrent CRSwNP. The study is prospective and conducted across multiple centers in China, enrolling around 200 patients diagnosed with CRSwNP and scheduled for surgical treatment. Participants will undergo standard-of-care endoscopic sinus surgery (ESS) performed according to routine clinical practice and local guidelines. This surgical procedure serves as the baseline event for prospective observation. Researchers will monitor clinical outcomes, including Sino-Nasal Outcome Test (SNOT)-22 scores, Nasal Polyp Scores, and CT findings, over a 52-week period following surgery. Treatment decisions remain under the discretion of treating physicians. During the study, participants will receive regular clinical assessments and follow-ups to track changes in symptoms, quality of life, medication use, and recurrence rates. Evaluations include questionnaires like SNOT-22, spirometry, CT scans, and various symptom scores at multiple time points up to one year. The study also observes systemic medication use and post-operative complications to provide a comprehensive view of patient outcomes and disease control after surgery.

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 arôms® 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.