Chronic RhinitisNCT06370468
The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis
An observational study of Chronic Rhinitis, run by Zheng Liu ENT at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- Epidemiological investigation
- How many people
- 150,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2024to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Nan Wang, 18162776268, nan.wang0303@hotmail.com
Zheng liu, 18607110505, zhengliuent@hotmail.com
About this study
Official title: To Elucidate the Epidemiological, Clinical, and Intrinsic Characteristics of Chronic Rhinitis
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.
Read the detailed description
- 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): 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)." The SPT is typically conducted on the volar side of the forearm, and it necessitates the cessation of medications that could interfere with the results, such as antihistamines, for a period of 3 to 7 days prior to the test. During the procedure, both a histamine positive control and a saline negative control are utilized. The recommended concentration for the histamine positive control is 10 mg/ml. A wheal diameter exceeding 3 mm is considered indicative of a positive reaction in the SPT. The test results should be evaluated between 15 to 20 minutes after the application of the allergens. It is important to note that some individuals may exhibit delayed reactions, which require medical attention if they occur. Patients testing positive are diagnosed with Allergic Rhinitis (AR), while those testing negative proceed to the subsequent diagnostic step.
- 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:
- Medication Suspension: Patients are instructed to cease the use of any medications that might interfere with the test outcomes, such as antihistamines and corticosteroid nasal sprays, typically for a period exceeding 48 hours prior to the test.
- Patient Evaluation: A comprehensive health assessment is performed to ensure that the patient does not exhibit severe nasal congestion or acute respiratory infections, as these conditions could distort the test results.
- Baseline Symptom Documentation: Before the test begins, the patient's current nasal symptoms, including congestion, rhinorrhea, sneezing, and nasal itching, are documented, preferably during asymptomatic periods.
- Allergen Preparation: Allergens, such as pollen, dust mites, animal dander, and molds, are prepared for the provocation. These allergens are diluted to appropriate concentrations for the test.
- Provocation Procedure: The allergen solution is introduced into the patient's nasal cavity, with the dosage and concentration being incrementally adjusted based on the patient's response by the overseeing physician.
- Symptom Observation and Documentation: Following allergen administration, the patient is monitored closely for the development of allergic symptoms. The severity and onset time of symptoms such as nasal congestion, rhinorrhea, and sneezing are recorded.
- Result Interpretation: The presence of allergic symptoms after provocation indicates an allergy to the introduced allergen, leading to a diagnosis of LAR.
- 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.
- Nasal eosinophilic infiltration: To assess the degree of local eosinophilic infiltration in the nasal cavity, a cytological analysis of nasal secretions is performed. This involves the collection of nasal secretions from the nasal cavity using swabs. The swabs are gently inserted into the nostrils and rotated to collect the necessary sample.
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:
- Preparation: Prior to the stimulation, the patient should be comfortably seated in a quiet, temperature-controlled room. It is important to ensure that the patient is not suffering from an acute upper respiratory infection or any other condition that might affect the results of the test.
- Equipment Setup: A device capable of delivering a controlled flow of dry cold air is used for the stimulation. The device should be able to maintain a temperature range of 5-15°C, a humidity level of 10%-15%, and a flow rate of 20-30 liters per minute, as these parameters have been determined to be provocative for individuals with hyperreactive nasal cavities.
- Patient Instruction: The patient is instructed to breathe normally through the nose during the procedure. They should be informed about what to expect during the stimulation and assured that the test is safe and monitored closely by the medical staff.
- Stimulation: The dry cold air is directed towards the patient's nostrils using a specialized nozzle.
- Duration: The stimulation typically lasts for a few minutes, usually between 5 and 10 minutes, depending on the patient's response. The duration can be adjusted based on the patient's tolerance and the appearance of symptoms.
- Symptom Monitoring: Throughout the stimulation, the patient's response is closely monitored for symptoms such as sneezing, nasal congestion, rhinorrhea (runny nose), and nasal itching. These symptoms indicate a hyperreactive response to the cold, dry air.
- Post-Stimulation Assessment: After the stimulation, the patient's nasal symptoms are assessed and recorded. Any relief or persistence of symptoms is noted, which can provide valuable information for the diagnosis of IR or other nasal hyperreactivity conditions.
- 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.
- Peripheral blood, serum, and/or nasal mucosal epithelial cells will be collected for Proteomic detection.
- Conditions
- Chronic Rhinitis
- Being tested
- Epidemiological investigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological investigationOther
Epidemiological investigation
| Study group | Role | What they receive |
|---|---|---|
| 18000 cases | 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. Receives: Other: Epidemiological investigation | |
| 132000 cases | 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. Receives: Other: Epidemiological investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2024.04-2025.04
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2024.04-2026.04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start27 Apr 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Liu ENT
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College, Hainan People's Hospital, Shandong Provincial Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor-investigator, Zheng Liu ENT, Tongji Hospital
- Investigators
- Zheng Liu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370468
- Sponsor's protocol ID
- 2024-CR-China
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: a
Publications
Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.
PubMed 1
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Elucidate the Epidemiological, Clinical, and Intrinsic Characteristics of Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT06370468
- Acronym / sponsor ID
- 2024-CR-China
- Conditions
- Chronic Rhinitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Zheng Liu ENTUniversity, hospital or other
- Collaborators
- Peking Union Medical College, Hainan People's Hospital, Shandong Provincial Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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): 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)." The SPT is typically conducted on the volar side of the forearm, and it necessitates the cessation of medications that could interfere with the results, such as antihistamines, for a period of 3 to 7 days prior to the test. During the procedure, both a histamine positive control and a saline negative control are utilized. The recommended concentration for the histamine positive control is 10 mg/ml. A wheal diameter exceeding 3 mm is considered indicative of a positive reaction in the SPT. The test results should be evaluated between 15 to 20 minutes after the application of the allergens. It is important to note that some individuals may exhibit delayed reactions, which require medical attention if they occur. Patients testing positive are diagnosed with Allergic Rhinitis (AR), while those testing negative proceed to the subsequent diagnostic step.
- 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:
- Medication Suspension: Patients are instructed to cease the use of any medications that might interfere with the test outcomes, such as antihistamines and corticosteroid nasal sprays, typically for a period exceeding 48 hours prior to the test.
- Patient Evaluation: A comprehensive health assessment is performed to ensure that the patient does not exhibit severe nasal congestion or acute respiratory infections, as these conditions could distort the test results.
- Baseline Symptom Documentation: Before the test begins, the patient's current nasal symptoms, including congestion, rhinorrhea, sneezing, and nasal itching, are documented, preferably during asymptomatic periods.
- Allergen Preparation: Allergens, such as pollen, dust mites, animal dander, and molds, are prepared for the provocation. These allergens are diluted to appropriate concentrations for the test.
- Provocation Procedure: The allergen solution is introduced into the patient's nasal cavity, with the dosage and concentration being incrementally adjusted based on the patient's response by the overseeing physician.
- Symptom Observation and Documentation: Following allergen administration, the patient is monitored closely for the development of allergic symptoms. The severity and onset time of symptoms such as nasal congestion, rhinorrhea, and sneezing are recorded.
- Result Interpretation: The presence of allergic symptoms after provocation indicates an allergy to the introduced allergen, leading to a diagnosis of LAR.
- 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.
- Nasal eosinophilic infiltration: To assess the degree of local eosinophilic infiltration in the nasal cavity, a cytological analysis of nasal secretions is performed. This involves the collection of nasal secretions from the nasal cavity using swabs. The swabs are gently inserted into the nostrils and rotated to collect the necessary sample.
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:
- Preparation: Prior to the stimulation, the patient should be comfortably seated in a quiet, temperature-controlled room. It is important to ensure that the patient is not suffering from an acute upper respiratory infection or any other condition that might affect the results of the test.
- Equipment Setup: A device capable of delivering a controlled flow of dry cold air is used for the stimulation. The device should be able to maintain a temperature range of 5-15°C, a humidity level of 10%-15%, and a flow rate of 20-30 liters per minute, as these parameters have been determined to be provocative for individuals with hyperreactive nasal cavities.
- Patient Instruction: The patient is instructed to breathe normally through the nose during the procedure. They should be informed about what to expect during the stimulation and assured that the test is safe and monitored closely by the medical staff.
- Stimulation: The dry cold air is directed towards the patient's nostrils using a specialized nozzle.
- Duration: The stimulation typically lasts for a few minutes, usually between 5 and 10 minutes, depending on the patient's response. The duration can be adjusted based on the patient's tolerance and the appearance of symptoms.
- Symptom Monitoring: Throughout the stimulation, the patient's response is closely monitored for symptoms such as sneezing, nasal congestion, rhinorrhea (runny nose), and nasal itching. These symptoms indicate a hyperreactive response to the cold, dry air.
- Post-Stimulation Assessment: After the stimulation, the patient's nasal symptoms are assessed and recorded. Any relief or persistence of symptoms is noted, which can provide valuable information for the diagnosis of IR or other nasal hyperreactivity conditions.
- 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.
- Peripheral blood, serum, and/or nasal mucosal epithelial cells will be collected for Proteomic detection.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18000 cases | – | Other: Epidemiological investigationThe 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. |
| 132000 cases | – | Other: Epidemiological investigationThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiological investigationEpidemiological investigation | Other | 132000 cases, 18000 cases |
Primary outcome
The prevalence chronic rhinitis within the Chinese population
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.
3 secondary outcomes
The distribution patterns of chronic rhinitis within the Chinese population
Time frame: 2024.04-2025.04
The risk factors of chronic rhinitis
Time frame: 2024.04-2025.04
The clinical features and endotype of chronic rhinitis
Time frame: 2024.04-2026.04
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 1Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.
- Individual participant dataSharing planned: Undecided. a
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zheng Liu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinitis, run by Zheng Liu ENT at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Liu, PI (008618607110505, zhengliuent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence chronic rhinitis within the Chinese population (time frame: 2024.04-2025.04). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.