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 procedure's 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 spray's effects.

Researchers are evaluating the safety, tolerability, and effectiveness of the gene therapy SENS-501 in children aged 6 to 31 months who have severe to profound hearing loss caused by mutations in the Otoferlin gene. This open-label Phase I/II study focuses on children with pre-lingual hearing loss due to these genetic mutations, aiming to better understand how this treatment works in this young population. The study involves administering SENS-501 directly into one ear using a special injection system. It includes a dose-escalation phase where children receive either a low or high dose, followed by a dose expansion phase where the dose recommended from earlier phases is given. The treatment is given as a single unilateral intracochlear injection, and the administration system's safety, performance, and usability are also evaluated. Participants will be followed for up to 5 years to monitor safety and tolerability and to assess hearing improvement using auditory brainstem response (ABR) and pure tone audiometry (PTA). Additional evaluations include clinical checks of the administration system shortly after treatment. Throughout the study, children will undergo hearing tests and medical assessments to measure outcomes and track any side effects or complications from the treatment and procedure.

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 conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.

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.