Nasal Obstruction

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 effects of two types of maxillary expanders used to widen the upper jaw in children aged 8 to 13 years with maxillary transverse deficiency. This trial compares a traditional expander made by hand in a laboratory to a newer expander designed on a computer and produced with 3D printing technology. The goal is to determine if the 3D-printed expander is as effective as the conventional one while potentially offering greater comfort to the patient. Participants will be randomly assigned to two groups one group receives the conventional laboratory-made Hyrax expander, and the other group receives the 3D-printed Hyrax expander. Both devices are used in the orthodontic clinic to treat upper jaw expansion. The treatment period includes follow-up visits over six months where dental photos, X-rays, and scans are taken to monitor progress. Patients and their parents or guardians will also complete online questionnaires about quality of life and pain experienced at various times during the study. During the study, participants will attend regular clinical visits for standard orthodontic follow-up, including photos, X-rays, and dental scans to assess the expanders effects. Researchers will measure changes in the midpalatal suture opening, interincisal diastema width, molar inclination, and maxillary arch widths after two weeks. Pain perception and oral health-related quality of life will also be evaluated using specific pain scales and questionnaires. This study lasts six months, with ongoing monitoring of treatment progress and patient comfort.

Researchers are studying people who use intravenous drugs PWIDs to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

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 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 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.

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.