An observational study in Chronic Rhinitis, sponsored by Zheng Liu ENT. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Zheng Liu ENT · Observational
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.
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:
Allergen nasal provocation (ANP): The ANP test is conducted to diagnose Local Allergic Rhinitis (LAR) by directly introducing allergens into the nasal cavity to induce nasal allergy symptoms. Here's a refined description of the procedure:
Symptom Relief: Should the patient experience significant allergic symptoms, relief may be provided through the administration of antihistamines or other appropriate medications.
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.
Dry cold air provocation test : To assess the high reactivity of the nasal cavity to physical stimulation, particularly in the context of Idiopathic Rhinitis (IR) or other nasal hyperreactivity conditions, a local nasal cavity stimulation with dry cold air can be performed. This stimulation is designed to replicate the exposure to cold, dry air that often triggers symptoms in individuals with sensitive nasal passages. Here's a detailed description of the procedure:
Safety Measures: It is essential to have emergency medications and equipment on hand in case the patient experiences an exaggerated reaction to the cold air stimulation.
This procedure allows healthcare professionals to evaluate the degree of nasal hyperreactivity to physical stimuli and can help diagnose of IR.
246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.
This study's planned enrollment of 150,000 is above the median of 246 across 52 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Zheng Liu ENT is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To estimate the incidence of chronic rhinitis in China, we calculate a sample size of roughly 9,471 patients using the formula n = (Z\^2 * p * (1-p))/E\^2, with Z = 1.96 for a 95% confidence level, p = 0.2 for a 20% prevalence, and E = 0.015 for a 1.5% margin of error. Our study includes recalling 3,000 patients for nasal exams, implying a need to survey 18 million subjects for a 20% incidence rate and 80% response rate. We'll use a multi-stage cluster sampling survey for 18,000 face-to-face questionnaires and distribute 132,000 electronic questionnaires to reach 30,000 chronic rhinitis patients, assuming a 20% prevalence.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The first part of the study will use a multi-stage cluster sampling survey, aiming to complete a questionnaire survey of 18,000 cases to assess the incidence and characteristics of chronic rhinitis. Each center will need to complete 3,000 face-to-face questionnaires to ensure reliable survey results.
Other: Epidemiological investigation
The second part will involve distributing 132,000 electronic questionnaires to community health service centers through convenient sampling. This method will allow us to obtain a large volume of questionnaire data more conveniently, thereby enhancing our investigation and analysis of chronic rhinitis. Each of the six centers will need to complete 22,000 online questionnaires.
Other: Epidemiological investigation
Epidemiological investigation
The prevalence chronic rhinitis within the Chinese population
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 distribution patterns of chronic rhinitis within the Chinese population
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 risk factors of chronic rhinitis
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: 2024.04-2025.04
The clinical features and endotype of chronic rhinitis
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.
Time frame: 2024.04-2026.04
Plan to share: Undecided — a
Started Apr 2024 (actual). Primary completion is estimated for May 2027, 36 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Zheng Liu ENT