The Cohort Study for Asthma in China

NCT ID: NCT05937334

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2028-12-31

Brief Summary

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The study is to establish a standardized asthma cohort study, build an information network platform system and a biospecimen bank for asthma cohort, establish clear follow-up standards and norms, observe the asthma outcomes and identify biomarkers to predict asthma outcomes.

Detailed Description

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This is a single center observational prospective longitudinal cohort study to establish a standardized asthma cohort, consisting of 400 patients with asthma. Baseline data including lung function test, chest CT, induced sputum, etc. was collected and the patients were followed up for 2 or more years. Subjects who met the 2023 GINA diagnostic criteria for asthma and were able to participate in the study according to the protocol and sign the informed consent were included. No additional investigational drugs will be applied to the patients. Blood samples are transported to designated laboratories for safekeeping and biomarker testing. We aimed to explore the mechanism of biomarkers involved in asthma pathogenesis and identify treatable traits related to disease outcome. Full analysis set will be used for all analyses. Missing data will be analyzed as it is. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure. Working group will do the data cleaning and data analyzing.

Conditions

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Asthma, Bronchial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Diagnostic Test: lung function test, chest CT, induced sputum, blood routine test, IgE test, FeNO test, six minutes walk test, questionnaires for asthma

lung function test, chest CT, induced sputum, blood routine test, IgE test, FeNO test, six minutes walk test, questionnaires for asthma were performed. All interventions was made according to routine diagnosis and treatment.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \>18
* Meet the 2023 edition of GINA asthma diagnostic criteria
* Subjects must sign informed consent prior to study participation, participate in the study according to the protocol and follow up for 2 years

Exclusion Criteria

* Suffering from other massive lung tissue destructive diseases such as severe bronchiectasis and tuberculosis
* Severe pleural disease and/or sternal and rib lesions
* Serious uncontrolled disease of other system
* Thoracic or abdominal surgery in the past 3 months
* Eye surgery in the past three months
* Retina detachment
* Myocardial infarction within the last 3 months
* Hospitalized for heart disease within the past 3 months
* Ongoing anti-tuberculosis treatment
* Pregnancy or breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kewu Huang

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kewu Huang, M.D.

Role: STUDY_DIRECTOR

Beijing Chao Yang Hospital

Locations

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Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Meishan Liu, M.D.

Role: CONTACT

8613141403749

Ying Wang, M.D.

Role: CONTACT

8613426121753

References

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Silverstein NJ, Huh JR. Interleukin-17: Why the Worms Squirm. Immunity. 2017 Mar 21;46(3):347-349. doi: 10.1016/j.immuni.2017.03.007.

Reference Type BACKGROUND
PMID: 28329701 (View on PubMed)

GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.

Reference Type BACKGROUND
PMID: 28822787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31230828 (View on PubMed)

Baptist AP, Busse PJ. Asthma Over the Age of 65: All's Well That Ends Well. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):764-773. doi: 10.1016/j.jaip.2018.02.007.

Reference Type BACKGROUND
PMID: 29747982 (View on PubMed)

Lange P, Colak Y, Ingebrigtsen TS, Vestbo J, Marott JL. Long-term prognosis of asthma, chronic obstructive pulmonary disease, and asthma-chronic obstructive pulmonary disease overlap in the Copenhagen City Heart study: a prospective population-based analysis. Lancet Respir Med. 2016 Jun;4(6):454-62. doi: 10.1016/S2213-2600(16)00098-9. Epub 2016 Apr 6.

Reference Type BACKGROUND
PMID: 27061878 (View on PubMed)

Fingleton J, Huang K, Weatherall M, Guo Y, Ivanov S, Bruijnzeel P, Zhang H, Wang W, Beasley R, Wang C; NZ-China Study Group. Phenotypes of symptomatic airways disease in China and New Zealand. Eur Respir J. 2017 Dec 7;50(6):1700957. doi: 10.1183/13993003.00957-2017. Print 2017 Dec.

Reference Type BACKGROUND
PMID: 29217598 (View on PubMed)

Bai TR, Vonk JM, Postma DS, Boezen HM. Severe exacerbations predict excess lung function decline in asthma. Eur Respir J. 2007 Sep;30(3):452-6. doi: 10.1183/09031936.00165106. Epub 2007 May 30.

Reference Type BACKGROUND
PMID: 17537763 (View on PubMed)

Vale-Pereira S, Todo-Bom A, Geraldes L, Schmidt-Weber C, Akdis CA, Mota-Pinto A. FoxP3, GATA-3 and T-bet expression in elderly asthma. Clin Exp Allergy. 2011 Apr;41(4):490-6. doi: 10.1111/j.1365-2222.2010.03640.x. Epub 2010 Nov 28.

Reference Type BACKGROUND
PMID: 21114556 (View on PubMed)

Dunn RM, Busse PJ, Wechsler ME. Asthma in the elderly and late-onset adult asthma. Allergy. 2018 Feb;73(2):284-294. doi: 10.1111/all.13258. Epub 2017 Sep 7.

Reference Type BACKGROUND
PMID: 28722758 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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YJXBF202201

Identifier Type: -

Identifier Source: org_study_id

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