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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05330637
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment
Asthma Allergic Rhinitis Chronic Obstructive Pulmonary Disease(COPD) Atopic Dermatitis Eczema Urticaria Bronchitis Bronchiectasis Adult Emphysema Other: Climate and environment in Sanya

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Influence of Climatic and Environmental Factors on Respiratory or Allergic Diseases in Sanya, Hainan Province, China.
Actual Study Start Date : March 3, 2022
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Migratory old people with asthma from northern China in Sanya
Migratory old people with asthma from northern China in Sanya have being expousured to two different climate and environment from northern China to Sanya for months.
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.

Migratory old people with allergic rhinitis from northern China in Sanya
Migratory old people with allergic rhinitis from northern China in Sanya have being expousured to two different climate and environment from northern China to Sanya for months.
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.

Migratory old people with Chronic Obstructive Pulmonary Disease (COPD) from northern China in Sanya
Migratory old people with Chronic Obstructive Pulmonary Disease (COPD) from northern China in Sanya have being expousured to two different climate and environment from northern China to Sanya for months.
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.

Migratory old people with atopic dermatitis from northern China in Sanya
Migratory old people with atopic dermatitis from northern China in Sanya have being expousured to two different climate and environment from northern China to Sanya for months.
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.

Children with asthma in Sanya
Children with asthma have being expousured to tropical climate and environment in Sanya for years.
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.

Children with allergic rhinitis in Sanya
Children with allergic rhinitis have being expousured to tropical climate and environment in Sanya for years.
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.

Children with atopic dermatitis in Sanya
Children with atopic dermatitis have being expousured to tropical climate and environment in Sanya for years.
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.

Children with eczema in Sanya
Children with eczema have being expousured to tropical climate and environment in Sanya for years.
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.

Children with urticaria in Sanya
Children with urticaria have being expousured to tropical climate and environment in Sanya for years.
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.

Migratory old people with eczema from northern China in Sanya
Migratory old people with eczema from northern China in Sanya have being expousured to two different climate and environment from northern China to Sanya for months.
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.

Migratory old people with urticaria from northern China in Sanya
Migratory old people with urticaria from northern China in Sanya have being expousured to two different climate and environment from northern China to Sanya for months.
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.




Primary Outcome Measures :
  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. [ Time Frame: 3 year ]
    The asthma, COPD, allergic rhinitis or atopic dermatitis will be diagnosed and assessed through history of diseases and questionnaire..


Secondary Outcome Measures :
  1. Asthma control of migratory old people with asthma. [ Time Frame: 1-3 year ]
    Quality of life is assessed through questionnaires of "Asthma Control Questionnaire (ACQ) ".

  2. Asthma life quality of migratory old people with asthma. [ Time Frame: 1-3 year ]
    Quality of life is assessed through questionnaires of "Asthma Quality of Life Questionnaire (AQLQ)".

  3. Lung function of migratory old people with asthma or COPD. [ Time Frame: 1-3 year ]
    Lung function is assessed through simple lung function test using spirometry.

  4. The respiratory function of migratory old people with COPD. [ Time Frame: 1-3 year ]
    Lung function is assessed through Saint George Respiratory Questionnaire (SGRQ).

  5. Allergens will be detected in migratory old people with asthma, allergic rhinitis or atopic dermatitis. [ Time Frame: 1-3 year ]
    Veinal blood was extracted to detect allergens.

  6. Inflammatory factors will be detected in migratory old people with asthma, allergic rhinitis or atopic dermatitis. [ Time Frame: 1-3 year ]
    Inflammatory factors such as esophageal granulocytes and eosinophils will be detected to assess inflammatory status of the migratory old people.

  7. The change of asthma incidence rate in migratory old people . [ Time Frame: 1-3 year ]
    Diagnosis and severity grading of asthma is based on the "American Thoracic Society" or the "National Heart, Lung, and Blood Institute guidelines."


Biospecimen Retention:   Samples Without DNA
Veinal blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05330637


Contacts
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Contact: Shijian Liu, Ph.D 86-21-38087983 liushijian@scmc.com.cn

Locations
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China, Hainan
Sanya Women and Children's Hospital, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University Recruiting
Sanya, Hainan, China
Contact: Haidao Guan, BD    86-0898-88360093    269941951@qq.com   
Principal Investigator: Shijian Liu, Ph.D         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Shijian Liu, Ph.D Shanghai Children's Medicial Center affiliated Shanghai Jiao Tong University School of Medicine
Publications of Results:

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Responsible Party: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT05330637    
Other Study ID Numbers: SYFYIRB2022009
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Jiao Tong University School of Medicine:
Asthma
Allergic Rhinitis
Climatotherapy
Chronic Obstructive Pulmonary Disease(COPD)
Atopic Dermatitis
Climate
Enviroment
Additional relevant MeSH terms:
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Rhinitis
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Rhinitis, Allergic
Bronchiectasis
Dermatitis, Atopic
Dermatitis
Eczema
Urticaria
Emphysema
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Respiratory Tract Infections
Infections
Nose Diseases
Otorhinolaryngologic Diseases
Pathologic Processes
Skin Diseases, Vascular