The Cohort Study for Asthma in China

Asthma, Bronchial Clinical Trial

Official title:

The Cohort Study for Asthma in China: an Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937334
• Other study ID #: YJXBF202201
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2023
• Source: Beijing Chao Yang Hospital
• Contact: Meishan Liu, M.D.
• Phone: 8613141403749
• Email: ccmuliumeishan[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Beijing Chao Yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Respir Med. 2017 Oct;5(10 ):e30. — 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, 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test(ACT)	As)thma control was assessed by Asthma Control Test(ACT)	2 years
Primary	Asthma Control Questionnaire(ACQ)	sthma control was assessed by Asthma Control Questionnaire(ACQ)	2 years
Primary	Induced sputum analysis	Identification of asthma endotypes was based on Induced sputum analysis	2 years
Secondary	Prognosis prediction of asthma with specific treatment regimen	Prognosis prediction of asthma with specific treatment regimen was based on different phenotypes and biomarkers	2 years