The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis

Chronic Rhinitis Clinical Trial

Official title: To Elucidate the Epidemiological, Clinical, and Intrinsic Characteristics of Chronic Rhinitis

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1. 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. 1.3 Specialist Examination and Biological Sample Collection: - Serum sIgE or skin prick tests (SPT) will be conducted to determine the presence of atopic constitution. The foundational allergen detection panel comprises the following allergens: dermatophagoides farinae, Dermatophagoides pteronyssinus, Artemisia vulgaris (mugwort), birch, Humulus lupulus (common hop), sycamore, cockroach, cat dander, dog dander, and Alternaria alternata (alternating Streptospora)." - Nasal secretions will be collected using cotton swabs for cytological analysis, and the detection of eosinophilic cationic protein or Charcot-Leyden crystal proteins to assess the degree of local eosinophilic infiltration in the nasal cavity. - Nasal allergen stimulation tests will be performed to detect the presence of local allergy in the nasal cavity. The allergen panel utilized for nasal provocation is identical to the one described in the skin prick test (SPT) section. - Local nasal cavity stimulation with dry cold air will be used to assess the high reactivity of the nasal cavity to physical stimulation. The parameters for dry cold air stimulation are as follows: a temperature range of 5-15°C, a humidity level of 10%-15%, and a flow rate of 20-30 liters per minute. - Peripheral blood, serum, and/or nasal mucosal epithelial cells will be collected for Proteomic detection. 2. Subject Selection 2. 1 Inclusion Criteria Subjects eligible for the questionnaire must meet the following criteria: they should be permanent residents of the survey site, Chinese nationals 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, and volunteers who are able to actively respond to the questionnaire and recall nasal symptoms experienced over the past year. 2.2 Exclusion Criteria Subjects will be excluded if they meet any of the following criteria: - Those who have undergone sinus or nasal surgery, or have been diagnosed with sinusitis, nasal polyps, or benign or malignant tumors of the nasal cavity and paranasal sinuses within the past year. - Individuals with primary cystic fibrosis or immotile cilia syndrome. - Residents living in specialized functional areas such as workshops, military bases, student dormitories, nursing homes, etc. - Those with mental disorders or cognitive impairments (including dementia, comprehension disorders, deafness, mutism, etc.). - Individuals who have recently been diagnosed with and are undergoing treatment for cancer. ;

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

• NCT number: NCT06370468
• Study type: Observational
• Source: Tongji Hospital
• Contact: Zheng Liu, PI
• Phone: 008618607110505
• Email: zhengliuent@hotmail.com
• Status: Not yet recruiting
• Start date: May 1, 2024
• Completion date: August 1, 2027