NCT05937334

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress56%
Jan 2023Dec 2028

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

5 years

First QC Date

April 21, 2023

Last Update Submit

June 30, 2023

Conditions

Asthma, Bronchial

Outcome Measures

Primary Outcomes (3)

  • Asthma Control Test(ACT)

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

    2 years

  • Asthma Control Questionnaire(ACQ)

    sthma control was assessed by Asthma Control Questionnaire(ACQ)

    2 years

  • Induced sputum analysis

    Identification of asthma endotypes was based on Induced sputum analysis

    2 years

Secondary Outcomes (1)

  • Prognosis prediction of asthma with specific treatment regimen

    2 years

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 28329701BACKGROUND

  • 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.

    PMID: 28822787BACKGROUND

  • 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.

    PMID: 31230828BACKGROUND

  • 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.

    PMID: 29747982BACKGROUND

  • 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.

    PMID: 27061878BACKGROUND

  • 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.

    PMID: 29217598BACKGROUND

  • 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.

    PMID: 17537763BACKGROUND

  • 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.

    PMID: 21114556BACKGROUND

  • 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.

    PMID: 28722758BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample, Induced sputum

MeSH Terms

Conditions

Asthma

Interventions

Fractional Exhaled Nitric Oxide TestingWalk Test

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Breath TestsDiagnostic Techniques and ProceduresDiagnosisExercise TestHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Kewu Huang, M.D.

    Beijing Chao Yang Hospital

    STUDY DIRECTOR

Central Study Contacts

Meishan Liu, M.D.

CONTACT

8613141403749ccmuliumeishan@163.com

Ying Wang, M.D.

CONTACT

8613426121753kokosalaki1020@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

April 21, 2023

First Posted

July 10, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

July 10, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)