NCT05330637

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

March 18, 2022

Last Update Submit

September 7, 2023

Conditions

Keywords

AsthmaAllergic RhinitisClimatotherapyChronic Obstructive Pulmonary Disease(COPD)Atopic DermatitisClimateEnvironment

Outcome Measures

Primary Outcomes (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..

    3 year

Secondary Outcomes (7)

  • Asthma control of migratory old people with asthma.

    1-3 year

  • Asthma life quality of migratory old people with asthma.

    1-3 year

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

    1-3 year

  • The respiratory function of migratory old people with COPD.

    1-3 year

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

    1-3 year

  • +2 more secondary outcomes

Study Arms (11)

Migratory old people with asthma from northern China in Sanya

Migratory 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.

Other: Climate and environment in Sanya

Migratory old people with allergic rhinitis from northern China in Sanya

Migratory 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.

Other: Climate and environment in Sanya

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 to Sanya have being exposure to two different climate and environment from northern China to Sanya for months.

Other: Climate and environment in Sanya

Migratory old people with atopic dermatitis from northern China in Sanya

Migratory 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.

Other: Climate and environment in Sanya

Children with asthma in Sanya

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

Other: Climate and environment in Sanya

Children with allergic rhinitis in Sanya

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

Other: Climate and environment in Sanya

Children with atopic dermatitis in Sanya

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

Other: Climate and environment in Sanya

Children with eczema in Sanya

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

Other: Climate and environment in Sanya

Children with urticaria in Sanya

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

Other: Climate and environment in Sanya

Migratory old people with eczema from northern China in Sanya

Migratory 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.

Other: Climate and environment in Sanya

Migratory old people with urticaria from northern China in Sanya

Migratory 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.

Other: Climate and environment in Sanya

Interventions

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 SanyaChildren with asthma in SanyaChildren with atopic dermatitis in SanyaChildren with eczema in SanyaChildren with urticaria in SanyaMigratory old people with Chronic Obstructive Pulmonary Disease (COPD) from northern China in SanyaMigratory old people with allergic rhinitis from northern China in SanyaMigratory old people with asthma from northern China in SanyaMigratory old people with atopic dermatitis from northern China in SanyaMigratory old people with eczema from northern China in SanyaMigratory old people with urticaria from northern China in Sanya

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • years-old migratory people with asthma, allergic rhinitis, COPD or atopic dermatitis from northern China;
  • years-old children in Sanya;
  • Agree to participate this study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanya Women and Children's Hospital, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

Sanya, Hainan, China

RECRUITING

Related Publications (14)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Veinal blood

MeSH Terms

Conditions

AsthmaRhinitis, AllergicPulmonary Disease, Chronic ObstructiveDermatitis, AtopicEczemaUrticariaBronchitisEmphysema

Interventions

ClimateEnvironment

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, VascularRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaAtmosphereMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Shijian Liu, Ph.D

    Shanghai Children's Medicial Center affiliated Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shijian Liu, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 15, 2022

Study Start

March 3, 2022

Primary Completion

December 31, 2023

Study Completion

April 30, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations