To Elucidate the Epidemiological, Clinical, and Intrinsic Characteristics of Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150,000
- 试验地点
- 1
- 主要终点
- The prevalence chronic rhinitis within the Chinese population
研究概览
简要总结
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.
详细描述
- Epidemiological Investigation 1.1 Survey Group Selection: This study aims to conduct an epidemiological survey of chronic rhinitis across various regions of China, including the north, central, south, east, and west. The objective is to gather epidemiological, demographic, and clinical information from 30,000 patients with chronic rhinitis (5,000 cases per center) through questionnaires. Assuming a prevalence rate of chronic rhinitis at 20% of the population, approximately 150,000 questionnaires will be required. To ensure the project's efficiency and scientific rigor, it is divided into two parts. Initially, a multi-stage cluster random sampling survey will be conducted, encompassing 18,000 cases for a face-to-face questionnaire survey to accurately assess the incidence and characteristics of chronic rhinitis. Using a multi-stage cluster random sampling method, three administrative districts will be randomly selected from the central urban area of each city, one street from each district, and two residential areas from each street. Cluster sampling will be used to collect 500 questionnaire results from residents aged 18 to 70 in each residential area.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The prevalence chronic rhinitis within the Chinese population
时间窗: 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.
次要结局
- The risk factors of chronic rhinitis(2024.04-2025.04)
- The clinical features and endotype of chronic rhinitis(2024.04-2026.04)
- The distribution patterns of chronic rhinitis within the Chinese population(2024.04-2025.04)
研究者
Zheng Liu ENT
Professor
Tongji Hospital