The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis

NCT06370468 | Recruiting DMC

• 1 other identifier: 2024-CR-China
• Study Type: observational
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinitis

Outcome Measures

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.

  2024.04-2025.04

Secondary Outcomes (3)

• The distribution patterns of chronic rhinitis within the Chinese population

  2024.04-2025.04

• The risk factors of chronic rhinitis

  2024.04-2025.04

• The clinical features and endotype of chronic rhinitis

  2024.04-2026.04

Study Arms (2)

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.

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.

Other: Epidemiological investigation

Interventions

Epidemiological investigation OTHER

Epidemiological investigation

132000 cases; 18000 cases

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Zheng Liu ENT: lead
• Peking Union Medical College: collaborator
• Hainan People's Hospital: collaborator
• Shandong Second Provincial General Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Study Sites (1)

Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 1 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, blood cells, urine, nasal secretion

Study Officials

• Zheng Liu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Liu, PI

CONTACT

008618607110505; zhengliuent@hotmail.com

Nan Wang, SubI

CONTACT

008618162776268; nan.wang0303@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: April 27, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

CN (1)