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AsthmaNCT05330637

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

An observational study of Asthma and Allergic Rhinitis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the Influence of Climatic and Environmental Factors on Respiratory or Allergic Diseases in Sanya. Read more about this study

Who is it for?
Ages 3 to 80 yearsHealthy volunteers can take part
What is being tested?
Climate and environment in Sanya
How many people
800 participants
Where
1 siteChina
Study dates
3 Mar 2022to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

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 3 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 1. 50-80 years-old migratory people with asthma, allergic rhinitis, COPD or atypical dermatitis from northeast China. 2. 3-12 years-old children with asthma, allergic rhinitis, atypical dermatitisin in Sanya.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Shijian Liu, Ph.D contact

86-21-38087983

liushijian@scmc.com.cn

China1 site, 1 recruiting
  • Sanya Women and Children's Hospital, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

    Sanya, Hainan

    Haidao Guan, BD, 86-0898-88360093, 269941951@qq.com

    Shijian Liu, Ph.D

    Recruiting

Other trials in China

About this study

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

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

Read the detailed 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.
Being tested
Climate and environment in Sanya
Keywords
Asthma, Allergic Rhinitis, Climatotherapy, Chronic Obstructive Pulmonary Disease(COPD), Atopic Dermatitis, Climate, Environment
Medical subject headings
Asthma, Rhinitis, Allergic, Pulmonary Disease, Chronic Obstructive, Dermatitis, Atopic, Eczema, Urticaria, Bronchitis, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Climate and environment in SanyaOther

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

Study groups in NCT05330637
Study groupRoleWhat they receive
Migratory old people with asthma from northern China in SanyaMigratory old people with asthma from northern China to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.
Receives: Other: Climate and environment in Sanya
Migratory old people with allergic rhinitis from northern China in SanyaMigratory old people with allergic rhinitis from northern China to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.
Receives: Other: Climate and environment in Sanya
Migratory old people with Chronic Obstructive Pulmonary Disease (COPD) from northern China in SanyaMigratory old people with Chronic Obstructive Pulmonary Disease (COPD) from northern China to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.
Receives: Other: Climate and environment in Sanya
Migratory old people with atopic dermatitis from northern China in SanyaMigratory old people with atopic dermatitis from northern China to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.
Receives: Other: Climate and environment in Sanya
Children with asthma in SanyaChildren with asthma have being exposure to tropical climate and environment in Sanya for years.
Receives: Other: Climate and environment in Sanya
Children with allergic rhinitis in SanyaChildren with allergic rhinitis have being exposure to tropical climate and environment in Sanya for years.
Receives: Other: Climate and environment in Sanya
Children with atopic dermatitis in SanyaChildren with atopic dermatitis have being exposure to tropical climate and environment in Sanya for years.
Receives: Other: Climate and environment in Sanya
Children with eczema in SanyaChildren with eczema have being exposure to tropical climate and environment in Sanya for years.
Receives: Other: Climate and environment in Sanya
Children with urticaria in SanyaChildren with urticaria have being exposure to tropical climate and environment in Sanya for years.
Receives: Other: Climate and environment in Sanya
Migratory old people with eczema from northern China in SanyaMigratory old people with eczema from northern China to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.
Receives: Other: Climate and environment in Sanya
Migratory old people with urticaria from northern China in SanyaMigratory old people with urticaria from northern China to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.
Receives: Other: Climate and environment in Sanya

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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..

    Measured: 3 year

Secondary outcomes (7)
  1. Asthma control of migratory old people with asthma.

    Quality of life is assessed through questionnaires of "Asthma Control Questionnaire (ACQ) ".

    Measured: 1-3 year

  2. Asthma life quality of migratory old people with asthma.

    Quality of life is assessed through questionnaires of "Asthma Quality of Life Questionnaire (AQLQ)".

    Measured: 1-3 year

  3. Lung function of migratory old people with asthma or COPD.

    Lung function is assessed through simple lung function test using spirometry.

    Measured: 1-3 year

  4. The respiratory function of migratory old people with COPD.

    Lung function is assessed through Saint George Respiratory Questionnaire (SGRQ).

    Measured: 1-3 year

  5. Allergens will be detected in migratory old people with asthma, allergic rhinitis or atopic dermatitis.

    Veinal blood was extracted to detect allergens.

    Measured: 1-3 year

  6. 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.

    Measured: 1-3 year

  7. 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."

    Measured: 1-3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start3 Mar 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05330637
Sponsor's protocol ID
SYFYIRB2022009
Status last verified
Sep 2023
First submitted
18 Mar 2022
Last updated
11 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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, Xiao D, Wang Z, Chen Z, Bu X, Zhang H, Zhang X, An L, Zhang S, Zhu J, Cao Z, Zhan Q, Yang Y, Liang L, Tong X, Dai H, Cao B, Wu T, Chung KF, He J, Wang C; China Pulmonary Health (CPH) Study Group. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019 Aug 3;394(10196):407-418. doi: 10.1016/S0140-6736(19)31147-X. Epub 2019 Jun 20.

    PubMed 31230828
  • 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. doi: 10.1016/j.rmed.2020.106198. Epub 2020 Oct 20.

    PubMed 33120194
  • 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.

    PubMed 29731623
  • 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. eCollection 2015.

    PubMed 26664107
  • 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 Phase I. World Allergy Organ J. 2020 Dec 5;14(1):100492. doi: 10.1016/j.waojou.2020.100492. eCollection 2021 Jan.

    PubMed 34659624
  • 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. Sci Total Environ. 2016 Feb 15;544:645-52. doi: 10.1016/j.scitotenv.2015.12.015. Epub 2015 Dec 10.

    PubMed 26674694
  • 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 rhinitis and respiratory symptoms: results from the Italian study of asthma in young adults. Allergy. 2004 Mar;59(3):306-14. doi: 10.1046/j.1398-9995.2003.00391.x.

    PubMed 14982513
  • 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.

    PubMed 15208377
  • 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/s13223-021-00532-7.

    PubMed 33750462
  • 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. doi: 10.3109/02770903.2013.808346.

    PubMed 23713625
  • 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. 2009 Jul;64(7):1083-92. doi: 10.1111/j.1398-9995.2009.01967.x. Epub 2009 Feb 11.

    PubMed 19210346
  • 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.

    PubMed 25336941
  • 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.

    PubMed 27417220
  • 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.

    PubMed 27957490

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Allergic Rhinitis, run by Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shijian Liu, Ph.D (86-21-38087983, liushijian@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 3 year). 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 NCT05330637, which also lists 14 linked publications.

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 11 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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