The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis
ConditionChronic Rhinitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorZheng Liu ENT
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Epidemiological investigation
Other interventionEpidemiological investigation
Treatment groups
150,000 Participants
are divided into 2 treatment groupsGroup A: 18000 cases1 intervention
Group B: 132000 cases1 intervention
Trial outcomes
Primary outcomes
1
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
2024.04-2025.04Secondary outcomes
1
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
2024.04-2025.042
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
2024.04-2025.043
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
2024.04-2026.04Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zheng Liu ENT
Lead sponsor
Tongji Hospital
Sponsor institution
Peking Union Medical College
Collaborator
Hainan People's Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Source ClinicalTrials.gov