Study on the Influence of Climatic and Environmental Factors on Respiratory Diseases in Sanya, Hainan Province, China.

Asthma Clinical Trial

Official title:

Study on the Influence of Climatic and Environmental Factors on Respiratory or Allergic Diseases in Sanya, Hainan Province, China.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330637
• Other study ID #: SYFYIRB2022009
• Status: Recruiting
• Start date: March 3, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: September 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Shijian Liu, Ph.D
• Phone: 86-21-38087983
• Email: liushijian[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the Influence of Climatic and Environmental Factors on Respiratory or Allergic Diseases in Sanya.

Description:

The study is an observational research, which will recruit the community migratory old people and children at school using cluster sampling in Sanya by Sanya Maternal and Child Health Care Hospital (Sanya Women and Children's Hospital). Sanya Central Hospital(Hainan Third People's Hospital) and People's Hospital of Sanya will assist to diagnose old people disease. The data of climate and environment will be obtained from Sanya Meteorological Administration and Sanya Municipal Ecology and Environment Bureau.

1. The primary purpose is to investigate the influence of the unique tropical climate and environmental factors on the migratory old people with diseases such as asthma, allergic rhinitis, COPD or atopic dermatitis in Sanya from northern China, and to provide scientific evidence for publicity of the tourism and the health care industry.

2. The secondary purpose is to investigate prevalence and risk factors of asthma, allergic rhinitis and atopic dermatitis among children in Sanya, which will provide a base for prevention and control strategies.

3. The third purpose is to retrospectively analyze the influence of climate and environmental factors in Sanya on children with asthma, allergic rhinitis and atopic dermatitis in the past decade, and a comparative analysis of the incidence on children in Sanya and Shanghai.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

Inclusion Criteria:

• 50-80 years-old migratory people with asthma, allergic rhinitis, COPD or atopic dermatitis from northern China;

• 3-12 years-old children in Sanya;

• Agree to participate this study.

Exclusion Criteria:

• Disagree to participate this study;

• Having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc;

• Inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Atopic Dermatitis
• Bronchiectasis
• Bronchiectasis Adult
• Bronchitis
• Chronic Obstructive Pulmonary Disease(COPD)
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Rhinitis
• Rhinitis, Allergic
• Urticaria

Intervention

Other:
• Climate and environment in Sanya
Sanya have unique island climate and environment campared with the north of China, with a feature of warm, moist and long-sunshine.

Locations

Country	Name	City	State
China	Sanya Women and Children's Hospital, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University	Sanya	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (14)

Ding Y, Xu J, Yao J, Chen Y, He P, Ouyang Y, Niu H, Tian Z, Sun P. The analyses of risk factors for COPD in the Li ethnic group in Hainan, People's Republic of China. Int J Chron Obstruct Pulmon Dis. 2015 Nov 30;10:2593-600. doi: 10.2147/COPD.S86402. eCol — View Citation

Donaldson GC, Wedzicha JA. The causes and consequences of seasonal variation in COPD exacerbations. Int J Chron Obstruct Pulmon Dis. 2014 Oct 6;9:1101-10. doi: 10.2147/COPD.S54475. eCollection 2014. — View Citation

Garcia-Almaraz R, Reyes-Noriega N, Del-Rio-Navarro BE, Berber A, Navarrete-Rodriguez EM, Ellwood P, Garcia Marcos Alvarez L; GAN Phase I group. Prevalence and risk factors associated with allergic rhinitis in Mexican school children: Global Asthma Network — View Citation

Huang K, Yang T, Xu J, Yang L, Zhao J, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Chen Y, Sun T, Shan G, Lin Y, Xu G, Wu S, Wang C, Wang R, Shi Z, Xu Y, Ye X, Song Y, Wang Q, Zhou Y, Li W, Ding L, Wan C, Yao W, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xia — View Citation

Kantor R, Silverberg JI. Environmental risk factors and their role in the management of atopic dermatitis. Expert Rev Clin Immunol. 2017 Jan;13(1):15-26. doi: 10.1080/1744666X.2016.1212660. Epub 2016 Jul 28. — View Citation

Li J, Sun B, Huang Y, Lin X, Zhao D, Tan G, Wu J, Zhao H, Cao L, Zhong N; China Alliance of Research on Respiratory Allergic Disease. A multicentre study assessing the prevalence of sensitizations in patients with asthma and/or rhinitis in China. Allergy. — View Citation

Pesce G, Bugiani M, Marcon A, Marchetti P, Carosso A, Accordini S, Antonicelli L, Cogliani E, Pirina P, Pocetta G, Spinelli F, Villani S, de Marco R. Geo-climatic heterogeneity in self-reported asthma, allergic rhinitis and chronic bronchitis in Italy. Sc — View Citation

Su N, Lin J, Chen P, Li J, Wu C, Yin K, Liu C, Chen Y, Zhou X, Yuan Y, Huang X. Evaluation of asthma control and patient's perception of asthma: findings and analysis of a nationwide questionnaire-based survey in China. J Asthma. 2013 Oct;50(8):861-70. do — View Citation

Wang X, Li LF, Zhao DY, Shen YW. Prevalence and Clinical Features of Atopic Dermatitis in China. Biomed Res Int. 2016;2016:2568301. doi: 10.1155/2016/2568301. Epub 2016 Nov 13. — View Citation

Wang X, Zhuang Y, Chen Y, Wang H, Wang X. Prevalence of adult eczema, hay fever, and asthma, and associated risk factors: a population-based study in the northern Grassland of China. Allergy Asthma Clin Immunol. 2021 Mar 9;17(1):27. doi: 10.1186/s13223-02 — View Citation

Weiland SK, Husing A, Strachan DP, Rzehak P, Pearce N; ISAAC Phase One Study Group. Climate and the prevalence of symptoms of asthma, allergic rhinitis, and atopic eczema in children. Occup Environ Med. 2004 Jul;61(7):609-15. doi: 10.1136/oem.2002.006809. — View Citation

Xie L, Liu Z, Hao S, Wu Q, Sun L, Luo H, Yu R, Li X, Wu X, Li S. Assessment of knowledge, attitude, and practice towards pulmonary rehabilitation among COPD patients: A multicenter and cross-sectional survey in China. Respir Med. 2020 Nov-Dec;174:106198. — View Citation

Zanolin ME, Pattaro C, Corsico A, Bugiani M, Carrozzi L, Casali L, Dallari R, Ferrari M, Marinoni A, Migliore E, Olivieri M, Pirina P, Verlato G, Villani S, Marco R; ISAYA Study Group. The role of climate on the geographic variability of asthma, allergic — View Citation

Zhu B, Wang Y, Ming J, Chen W, Zhang L. Disease burden of COPD in China: a systematic review. Int J Chron Obstruct Pulmon Dis. 2018 Apr 27;13:1353-1364. doi: 10.2147/COPD.S161555. eCollection 2018. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of migratory old people with asthma, COPD, allergic rhinitis or atopic dermatitis between winter-spring season in tropical Sanya, Hainan Island and summer-autumn season in northeast China.	The asthma, COPD, allergic rhinitis or atopic dermatitis will be diagnosed and assessed through history of diseases and questionnaire..	3 year
Secondary	Asthma control of migratory old people with asthma.	Quality of life is assessed through questionnaires of "Asthma Control Questionnaire (ACQ) ".	1-3 year
Secondary	Asthma life quality of migratory old people with asthma.	Quality of life is assessed through questionnaires of "Asthma Quality of Life Questionnaire (AQLQ)".	1-3 year
Secondary	Lung function of migratory old people with asthma or COPD.	Lung function is assessed through simple lung function test using spirometry.	1-3 year
Secondary	The respiratory function of migratory old people with COPD.	Lung function is assessed through Saint George Respiratory Questionnaire (SGRQ).	1-3 year
Secondary	Allergens will be detected in migratory old people with asthma, allergic rhinitis or atopic dermatitis.	Veinal blood was extracted to detect allergens.	1-3 year
Secondary	Inflammatory factors will be detected in migratory old people with asthma, allergic rhinitis or atopic dermatitis.	Inflammatory factors such as esophageal granulocytes and eosinophils will be detected to assess inflammatory status of the migratory old people.	1-3 year
Secondary	The change of asthma incidence rate in migratory old people .	Diagnosis and severity grading of asthma is based on the "American Thoracic Society" or the "National Heart, Lung, and Blood Institute guidelines."	1-3 year