Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370468
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-12
Brief Title:
The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis
Sponsor:
Zheng Liu ENT
Organization:
Tongji Hospital
Study Overview
Official Title:
To Elucidate the Epidemiological Clinical and Intrinsic Characteristics of Chronic Rhinitis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic rhinitis affects 10-40 of Chinas 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 diseases complexity and a lack of new treatment targets The incidence is rising but theres 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 rhinitiss causes and risks improve treatments and develop preventive strategies The study will survey 30000 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 diseases mechanisms developing new diagnostics and tailoring prevention and treatment approaches for different forms of chronic rhinitis
Detailed Description:
1 Epidemiological Investigation 11 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 30000 patients with chronic rhinitis 5000 cases per center through questionnaires Assuming a prevalence rate of chronic rhinitis at 20 of the population approximately 150000 questionnaires will be required To ensure the projects efficiency and scientific rigor it is divided into two parts Initially a multi-stage cluster random sampling survey will be conducted encompassing 18000 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 132000 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
12 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
13 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 mgml 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 Heres a refined description of the procedure
1 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
2 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
3 Baseline Symptom Documentation Before the test begins the patients current nasal symptoms including congestion rhinorrhea sneezing and nasal itching are documented preferably during asymptomatic periods
4 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
5 Provocation Procedure The allergen solution is introduced into the patients nasal cavity with the dosage and concentration being incrementally adjusted based on the patients response by the overseeing physician
6 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
7 Result Interpretation The presence of allergic symptoms after provocation indicates an allergy to the introduced allergen leading to a diagnosis of LAR
8 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 Heres a detailed description of the procedure
1 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
2 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 5-15C 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
3 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
4 Stimulation The dry cold air is directed towards the patients nostrils using a specialized nozzle
5 Duration The stimulation typically lasts for a few minutes usually between 5 and 10 minutes depending on the patients response The duration can be adjusted based on the patients tolerance and the appearance of symptoms
6 Symptom Monitoring Throughout the stimulation the patients 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
7 Post-Stimulation Assessment After the stimulation the patients 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
8 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 andor nasal mucosal epithelial cells will be collected for Proteomic detection
For the remaining 132000 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
12 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
13 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 mgml 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 Heres a refined description of the procedure
1 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
2 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
3 Baseline Symptom Documentation Before the test begins the patients current nasal symptoms including congestion rhinorrhea sneezing and nasal itching are documented preferably during asymptomatic periods
4 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
5 Provocation Procedure The allergen solution is introduced into the patients nasal cavity with the dosage and concentration being incrementally adjusted based on the patients response by the overseeing physician
6 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
7 Result Interpretation The presence of allergic symptoms after provocation indicates an allergy to the introduced allergen leading to a diagnosis of LAR
8 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 Heres a detailed description of the procedure
1 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
2 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 5-15C 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
3 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
4 Stimulation The dry cold air is directed towards the patients nostrils using a specialized nozzle
5 Duration The stimulation typically lasts for a few minutes usually between 5 and 10 minutes depending on the patients response The duration can be adjusted based on the patients tolerance and the appearance of symptoms
6 Symptom Monitoring Throughout the stimulation the patients 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
7 Post-Stimulation Assessment After the stimulation the patients 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
8 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 andor nasal mucosal epithelial cells will be collected for Proteomic detection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None