Acute Rhinitis

Researchers are conducting a long-term observational study across Europe to understand acute respiratory infections (ARI) in adults and children visiting primary care. The study aims to describe how ARI presents and is managed in community care, including infections caused by known and emerging respiratory pathogens. This research will help prepare for future clinical trials by building a research-ready infrastructure in primary care settings. Participants in this study may be part of one of three study protocols: POS-ARI-PC AUDIT, POS-ARI-PC CORE, or the embedded POS-ARI-PC-001 study. The AUDIT protocol involves anonymous registration of ARI cases presenting at primary care facilities. The CORE protocol includes detailed observational study with patient sampling and 28-day follow-up. The embedded POS-ARI-PC-001 study focuses on older adults or those with long-term health conditions and includes swab collection and follow-up procedures. During participation, patients will complete questionnaires about their symptoms and provide throat/nose swabs for analysis. They will be asked to report daily on their health status for up to 14 days using online or paper diaries. Researchers will also review clinical outcomes and hospital referrals up to 28 days after enrollment. Some participants may join optional interviews to share their experiences. The study collects data on illness severity, diagnosis, management, medication use, and return to daily activities to better inform future care and research.

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.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial sponsored by Tasly Pharmaceutical Group Co., Ltd. It aims to assess how well Antiwei granules work and how safe they are in adults aged 18 to 65 with recent onset of common cold symptoms. Participants will be randomly assigned to receive either Antiwei granules or a matching placebo. The treatment involves taking one sachet of granules (6 grams) orally three times a day, for three days. Both groups follow the same dosing schedule, taking nine sachets total. The study compares outcomes between the Antiwei granule group and the placebo group over this short treatment period. Throughout the trial, participants will be closely monitored with assessments focusing on the cure rate after three days of treatment. Researchers will also track symptom recovery time, remission rate, disappearance of individual symptoms, traditional Chinese medicine syndrome efficacy, changes in symptom severity, occurrence of complications, emergency medication use, and overall cure of cough and cold symptoms. The total participation time includes the three-day treatment and monitoring period to evaluate treatment effects and safety.

This research aims to understand how co-existing health conditions, medical history, and allergy tests affect the results of allergen provocation tests in children. The study includes children from birth up to 18 years old who are being investigated for allergies to foods or antibiotics. It is a prospective observational study conducted at the Hans Christian Andersen Children's Hospital. Participants undergo oral provocation tests where small, increasing amounts of allergens are given to assess allergic reactions. The allergens studied include antibiotics and a variety of common food allergens such as milk, egg, peanut, hazelnut, sesame, wheat, various nuts, soy, fish, shellfish, and poppy seed. Each child is assigned to a group based on the specific allergen they are being tested for. During the study, data on demographics, co-existing conditions, symptoms, skin prick tests, specific IgE levels, and details from the provocation tests are collected and entered into a database. Researchers will assess the relationship between allergy test results and provocation outcomes over a five-year period. Children will be monitored through these evaluations to better understand allergy responses and test effectiveness.

Researchers are investigating whether adding a diagnostic test that can distinguish whether an acute respiratory illness is caused by bacteria or viruses early in the evaluation can improve patient management and reduce healthcare resource use. The study focuses on adults presenting to the Emergency Department (ED) with undiagnosed respiratory infections who meet SIRS criteria and require immediate blood tests and treatment. The goal is to see if this test affects decisions about further diagnostic work, antimicrobial use, hospital stay length, and related costs. Participants are randomly assigned to one of two groups. The experimental group receives the usual care plus results from the MeMed BVae biomarker test, which analyzes a blood sample to provide a score that may help guide treatment. The control group receives standard care without the test results. Both groups are managed by clinicians following standard practice protocols. The study aims to compare outcomes such as additional testing, use of antibiotics, hospital admissions, and length of stay between these groups. During the study, participants will be monitored from admission to the ED through about 28 days of follow-up. Researchers will track costs related to diagnostic tests, consultations, antimicrobial treatments, hospital stays, and emergency department visits. They will also assess hospital length of stay up to six months post-admission, the number of patients returning to the ED within 72 hours, and appropriate antibiotic use based on infection type. Safety and patient management quality will be evaluated by reviewing these clinical and resource measures.

Researchers are evaluating the safety and effectiveness of stopping antibiotic treatment early in adults hospitalized with respiratory viral infections. This study focuses on patients with moderately severe disease who test positive for respiratory viruses such as influenza, respiratory syncytial virus, parainfluenza virus, or human metapneumovirus. The goal is to determine if early discontinuation of antibiotics leads to similar clinical outcomes compared to continuing antibiotic therapy, aiming to reduce unnecessary antibiotic use and combat antimicrobial resistance. Participants are randomly assigned to either stop antibiotic therapy as started by their admitting physician or to continue antibiotic therapy without changes. The study monitors early clinical response at 120 hours after randomization, defined by survival with symptom improvement and no need for rescue antibiotics. Secondary assessments include mortality rates, hospital stay duration, antibiotic use, and readmission rates, all measured during hospital admission and up to 30 days after discharge. During the trial, participants undergo nasopharyngeal swab testing to confirm viral infection and are monitored closely for symptoms, survival, and antibiotic use. Researchers evaluate clinical response at 120 hours and track outcomes such as mortality, hospital stay length, and antibiotic doses until discharge and 30 days later. The study aims to gather detailed safety and efficacy data over the hospital stay and follow-up period, supporting more targeted antibiotic use in viral respiratory infections.

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 evaluating the safety and effectiveness of photodisinfection therapy (PDT) using the Steriwave14 ND System compared to a control swabbing with a photosensitizer formulation in patients undergoing nasal surgery. This pilot trial aims to reduce the use of antibiotics for presumed surgical site infections (SSI) by eliminating harmful bacteria in the nasal passages before surgery. The study also investigates how well nasal decolonisation removes Staphylococcus aureus and other microbes from the nose, which could help prevent infections after surgery. Participants will be randomly assigned to either receive nasal PDT, which involves two applications of a photosensitizer solution containing methylene blue and chlorhexidine followed by light therapy, or to a control group where their noses are swabbed twice with the photosensitizer solution without light exposure. The PDT treatment is administered in two two-minute cycles before surgery using a CE-marked device and disposable applicators. The control group undergoes the swabbing procedure only. All patients will receive standard post-operative care and wound follow-up according to their surgery type. Before treatment, nasal swabs and flexible nasendoscopy will be done to measure bacterial colonization and inflammation. Participants will have repeat swabs and endoscopy about two weeks after surgery, and a telephone follow-up at 30 days to check antibiotic use and signs of infection. Researchers will assess antibiotic usage, incidence of SSI, nasal bacterial cultures, and inflammation scores. The total follow-up period is 30 days, during which any post-operative interventions will be documented to evaluate the therapy's safety and effectiveness.

Researchers are evaluating the effects of balloon sinuplasty treatment compared to a placebo in adults with chronic or recurrent maxillary sinusitis without nasal polyposis. The study aims to determine how effective balloon sinuplasty is in treating maxillary sinusitis and to identify which patients may benefit most. Additionally, the study investigates whether balloon sinuplasty improves Eustachian tube dysfunction. A total of 120 patients are enrolled, divided equally between chronic and recurrent maxillary sinusitis groups, with random assignment to either balloon sinuplasty or placebo treatment. The treatments are performed under local anesthesia in a day surgery setting. In the balloon sinuplasty group, a flexible balloon device is inserted and inflated in the maxillary sinus ostium to dilate it, while the placebo group undergoes a sham procedure mimicking the balloon inflation without the actual treatment. Both groups have the procedure performed on both maxillary sinuses. The study staff and patients are kept unaware of the treatment assignment to maintain blinding. Patients are followed for 12 months after the operation, with evaluations at 3, 6, 9, and 12 months. Participants complete questionnaires including the Sino-Nasal Outcome Test (SNOT-22) and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Clinical assessments include nasal endoscopy, rhinomanometry, tympanometry, tubomanometry, and Cone Beam Computed Tomography (CBCT) scans before and after treatment. Biopsies of nasal mucosa are taken during the operation and after 12 months. Researchers also track sinus infection episodes, antibiotic use, sick leaves, and symptom severity using visual scales. The study's primary outcomes focus on changes in quality of life and infection frequency, with safety and effectiveness monitored throughout.

Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.