Sinusitis

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.

This research aims to develop and test a modified minimally invasive surgical technique for sinus floor augmentation in patients with a residual bone height of 3 to 6 millimeters. The goal is to create a reliable implant bed of at least 10 millimeters in height after a healing period of 3 to 5 months. The study also seeks to reduce patient stress compared to traditional methods. Participants will undergo the sinus floor elevation procedure, which is being evaluated to improve outcomes and comfort. This surgical technique is studied on a pilot group of 12 patients, with no placebo or comparative treatments involved. The procedure targets the maxillary sinus area to enhance bone structure for dental implant placement. During the study, participants will be monitored to measure the height of bone augmentation after 4 to 5 months of healing. The research team will assess the surgical results and patient recovery, including any side effects or complications. The total duration includes the surgery followed by the healing and evaluation period to determine the procedures effectiveness and patient impact.

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 the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy SBRT to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

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.

Researchers are evaluating the ability of the AeviceMD, a wearable medical device, to detect wheezing in both children and adults. Wheezing, cough, and breathlessness are common respiratory symptoms usually identified manually by healthcare professionals through listening to lung sounds. The study aims to find out if AeviceMD can detect wheezes as accurately as a physician and to explore its potential for remote lung sound monitoring. During the study, participants will have the AeviceMD device placed on them to record lung sounds and detect wheezes. The devices findings will be compared with assessments made by physicians through traditional auscultation. The study includes two groups patients diagnosed with acute asthma exacerbations and patients with other non-cardiac and non-pulmonary complaints. Participants will undergo lung sound recordings both onsite with a physician and remotely, with the results compared between the AeviceMD device and medical professionals. The primary outcome is the detection of wheeze within 60 seconds, while the secondary outcome involves identifying respiratory sounds within 150 seconds. The study is observational and will continue until December 2026, involving children aged 3 years and older.

Researchers are investigating early warning signs and biomarkers for dementia with Lewy bodies DLB, a common cause of dementia linked to the buildup of misfolded alpha-synuclein protein in the brain. The study focuses on people with idiopathic olfactory dysfunctionloss or reduction of smell without known causeto better understand symptom progression and improve early diagnosis, potentially aiding future treatments. Participants include people with and without olfactory dysfunction. The study uses Real-Time Quaking-Induced Conversion RT-QuIC, a laboratory technique that detects misfolded alpha-synuclein, to assess samples from participants. It involves an exploratory cross-sectional case-control design and a long-term follow-up using Danish health registries to track diagnoses of Parkinsons disease or dementia. During the study, participants undergo smell tests, motor function exams, cognitive assessments, and evaluations of other symptoms related to Parkinsons disease and DLB at regular intervals over 24 months and longer. Researchers monitor the presence of misfolded alpha-synuclein and track diagnoses over up to 8 years. This observational study helps identify early signs and disease progression markers while participants continue their usual care.