AzTrials
AzTrials

Asthma, BronchialNCT05937334

The Cohort Study for Asthma in China

An observational study of Asthma, Bronchial, run by Beijing Chao Yang Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma, Bronchial
What is being tested?
Diagnostic Test: lung function test, chest CT, induced sputum, blood routine test, IgE test, FeNO test, six minutes walk test, questionnaires for asthma
How many people
400 participants
Where
1 siteChina
Study dates
1 Jan 2023to 31 Dec 2028
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: About 400 subjects will be recruited from Beijing Chao-Yang Hospital, Capital Medical University. They are over 18 years old, meet the 2023 version of GINA asthma diagnostic criteria, can participate in the study according to the protocol, and sign informed consent before participating in the study.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Myocardial infarction within the last 3 months
  • Hospitalized for heart disease within the past 3 months
  • Ongoing anti-tuberculosis treatment
  • Pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meishan Liu, M.D. contact

8613141403749

ccmuliumeishan@163.com

Ying Wang, M.D. contact

8613426121753

kokosalaki1020@sina.com

China1 site, 1 recruiting

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Diagnostic Test: lung function test, chest CT, induced sputum, blood routine test, IgE test, FeNO test, six minutes walk test, questionnaires for asthma
Medical subject headings
Asthma

What participants receive

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

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

    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.

What is being measured

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

  1. Asthma Control Test(ACT)

    As)thma control was assessed by Asthma Control Test(ACT)

    Measured: 2 years

  2. Asthma Control Questionnaire(ACQ)

    sthma control was assessed by Asthma Control Questionnaire(ACQ)

    Measured: 2 years

  3. Induced sputum analysis

    Identification of asthma endotypes was based on Induced sputum analysis

    Measured: 2 years

Secondary outcomes (1)

  1. Prognosis prediction of asthma with specific treatment regimen

    Prognosis prediction of asthma with specific treatment regimen was based on different phenotypes and biomarkers

    Measured: 2 years

Timeline

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

  1. First posted10 Jul 2023
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (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
400 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05937334
Sponsor's protocol ID
YJXBF202201
Status last verified
Jun 2023
First submitted
21 Apr 2023
Last updated
10 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28329701

  • 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.

    PubMed 28822787

  • 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

  • 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.

    PubMed 29747982

  • 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.

    PubMed 27061878

  • 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.

    PubMed 29217598

  • 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.

    PubMed 17537763

  • 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.

    PubMed 21114556

  • 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.

    PubMed 28722758

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, Bronchial, run by Beijing Chao Yang Hospital 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 10 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Meishan Liu, M.D. (8613141403749, ccmuliumeishan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control Test(ACT) (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT05937334, which also lists 9 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 10 Jul 2023.

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