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 throatnose 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 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 Childrens 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 arms 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.

This research evaluates nasal photodisinfection therapy PDT using the Steriwave123 ND System compared to a control group receiving only a photosensitizer formulation in patients undergoing nasal surgery. The study aims to assess the safety and effectiveness of PDT in reducing post-operative complications, especially the need for antibiotics due to surgical site infections. It focuses on patients scheduled for elective nasal surgeries and examines bacterial colonization and mucosal inflammation before and after treatment. Participants are randomly assigned to either receive nasal PDT, involving two applications of a photosensitizer solution activated by light, or control treatment with two swabs of the photosensitizer solution without light activation. Both groups undergo nasal swab cultures and flexible nasendoscopy to assess bacterial presence and inflammation before treatment and about two weeks after surgery. Standard post-operative care is provided to all patients. During the study, participants will have a baseline nasal culture and endoscopic evaluation before surgery, a follow-up in-person review around two weeks after surgery to assess antibiotic use and surgical site infections, and a telephone follow-up at 30 days to monitor antibiotic use and any adverse events. The study measures antibiotic usage, incidence of surgical site infection, nasal bacterial colonization, and mucosal inflammation using specific scoring methods over 30 days following surgery.

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 studys 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 procedure to clear sinus cavities, remove inflamed tissue, and enhance sinus medication use. This trial evaluates whether injecting a combination of local anesthetic and vasoconstrictor during ESS improves the surgeons view compared to no injection. Previous studies indicated saline injections may have similar effects, so this study aims to clarify the benefit of the drug combination during surgery. Participants are randomly assigned to one of two groups one receives an injection of 0.25% bupivacaine with epinephrine, and the other undergoes a sham injection involving only a puncture without medication. The trial is double-blinded, so neither participants nor surgeons know which procedure is given. The study takes place during the one-day surgery visit. During the procedure, researchers assess bleeding using the Boezzart bleeding score along with total blood loss, surgical time, blood pressure, postoperative bleeding, and pain. These measures are recorded throughout the surgery day. The study aims to enroll adults aged 19 and older scheduled for primary ESS, with follow-up focused on surgical conditions and recovery outcomes.

Researchers are studying children aged 7 to 11 to understand how physical activity in areas with high air pollution affects lung health compared to rest in the same conditions. The study focuses on children attending schools classified by their air pollution levels, aiming to assess airway resistance and inflammation related to pollution exposure during physical activity versus sedentary behavior. Participants will be randomly assigned to either a 90-minute outdoor physical education PE lesson or a 90-minute outdoor science lesson, both conducted in their school playgrounds. During these sessions, children will wear activity monitors to track their movements, and air pollution levels will be recorded. Lung health assessments including height, weight, breathing tests, and nasal samples will be collected before and after the sessions. Children will be assessed on two separate days, with lung function and immune response tests conducted immediately after and 24 hours post-exposure. The study involves about four hours of total participation time, including health assessments and activity or rest sessions. Researchers will compare lung health changes between children in higher and lower pollution schools to understand the impact of air pollution during physical activity.