Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT06370468
Chronic rhinitis affects 10-40% of China's population, or over 300 million people, and can lead to respiratory and psychological issues. Despite treatment progress, 30% of patients have poor outcomes, likely due to the disease's complexity and a lack of new treatment targets. The incidence is rising, but there's a lack of nationwide studies on its variations. This study addresses this through a multicentric survey to create a national database on chronic rhinitis, including epidemiological, clinical, and biological data. The goal is to understand chronic rhinitis's causes and risks, improve treatments, and develop preventive strategies. The study will survey 30,000 patients across China, using questionnaires and nasal exams, and preserve biological samples in a biobank for detailed analysis. This will lay the groundwork for understanding the disease's mechanisms, developing new diagnostics, and tailoring prevention and treatment approaches for different forms of chronic rhinitis.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Wuhan, Hubei, 430030, China
Location status: Recruiting
For the remaining 132,000 questionnaires, electronic questionnaires will be distributed to communities or community health service centers for online surveys using convenient sampling methods. Residents aged 18 to 70 will be encouraged to participate, and the data will be collected and analyzed.
1.2 Survey Indicators: Volunteers who respond positively to "whether they have chronic rhinitis" will be surveyed using a general information questionnaire and a chronic rhinitis-specific questionnaire.
The chronic rhinitis questionnaire primarily covers the following areas: living environment, symptoms experienced, medical history, and the pattern of disease manifestation (intermittent or persistent). It also inquires about the impact on daily life, including a severity assessment, potential predisposing factors, diagnostic methods employed (such as allergen testing), treatment approaches (including surgery, medication, and desensitization therapy), the level of disease control achieved, presence of any concurrent diseases, and the types of allergic conditions prevalent among family members.
Chronic rhinitis patients who successfully complete the face-to-face questionnaire and demonstrate good cooperation will be provided with a free nasal examination voucher and invited to the center for a specialist examination and the collection of corresponding biological specimens.
1.3 Specialist Examination and Biological Sample Collection:
This diagnostic test is potent but requires professional medical supervision due to the inherent risk of triggering severe allergic reactions. Emergency preparedness is essential throughout the procedure to ensure patient safety.
Once the sample is collected, it is then subjected to cytological analysis. This analysis involves examining the nasal secretions under a microscope to identify and quantify the presence of eosinophils, which increases in number in patients with NARES.
In addition to cytological analysis, the detection of specific biomarkers such as eosinophilic cationic protein (ECP) and Charcot-Leyden crystal proteins can provide further insight into the degree of local eosinophilic infiltration and activation. ECP is a protein released by activated eosinophils and is associated with the cytotoxic activity of these cells. Charcot-Leyden crystals are hexagonal crystalloid structures that form within the secretions of eosinophils and can be identified in cytological preparations.
By combining the results of cytological analysis with the detection of these biomarkers, healthcare professionals can obtain a comprehensive assessment of the degree of local eosinophilic infiltration in the nasal cavity. This information can be useful in the diagnosis of NARES.
This procedure allows healthcare professionals to evaluate the degree of nasal hyperreactivity to physical stimuli and can help diagnose of IR.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Chinese aged between 18 and 70 years old who have resided at the survey site for more than 6 months within the 12 months preceding the survey.
Exclusion criteria
Exclusion criteria
for questionnaire recipients: ① residents in specialized facilities (e.g., workshops, military barracks, student dormitories, nursing homes); individuals with mental or cognitive disorders (including dementia, aphasia, deafness); Exclusion criteria for nasal examination participants: ① individuals who have undergone sinus or nasal surgery, or diagnosed with sinusitis, nasal polyps, or nasal/nasopharyngeal tumors in the past year; ② patients with cystic fibrosis or primary ciliary dyskinesia; ③ residents in specialized facilities (e.g., workshops, military barracks, student dormitories, nursing homes); individuals with mental or cognitive disorders (including dementia, aphasia, deafness); (5) individuals currently under treatment for newly diagnosed tumors; ⑥ volunteers deemed unsuitable for the study by the research team.
Epidemiological investigation
Time frame: 2024.04-2025.04
The overall prevalence of chronic rhinitis across the Chinese population will be discribed. This will provide a demographic breakdown of how common chronic rhinitis is among various segments of the population.
Time frame: 2024.04-2025.04
The prevalence of subtype of chronic rhinitis, including allergic rhinitis, local allergic rhinitis, Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES), and Intrinsic Rhinitis (IR). The study will detail the percentage of patients suffering from each type of rhinitis within the Chinese population.
Time frame: 2024.04-2025.04
The correlation of chronic rhinitis with various factors, such as environmental influences, personal occupation, genetic susceptibility, disease severity, and the methods used for diagnosis and treatment.
Time frame: 2024.04-2026.04
Utilizing proteomic detection techniques, the study will analyze peripheral blood, serum, and nasal secretions to identify biological indicators associated with chronic rhinitis. These molecular markers will be correlated with the clinical classification of rhinitis, as established through epidemiological investigation and clinical assessment.
Contact information is provided by the study sponsor or research team.
Nan Wang, SubI
CONTACT
Zheng Liu, PI
CONTACT
Zheng Liu ENT
Other
To Elucidate the Epidemiological, Clinical, and Intrinsic Characteristics of Chronic Rhinitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06598319
Chronic Rhinitis, Infections
Colorado Springs, Colorado, United States
View Trial DetailsNCT06999044
Chronic Rhinitis
Nanjing, Jiangsu, China
View Trial DetailsNCT05626621
Chronic Rhinitis
Evanston, Illinois, United States
View Trial DetailsNCT07706595
Chronic Rhinitis, Common Cold
La Jolla, California, United States
View Trial Details