The Cohort Study for Asthma in China

Recruiting

• Conditions: Asthma, Bronchial

• Registration Number: NCT05937334
• Lead Sponsor: Beijing Chao Yang Hospital

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.

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-04-21
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Control Test(ACT)	2 years	As)thma control was assessed by Asthma Control Test(ACT)
Induced sputum analysis	2 years	Identification of asthma endotypes was based on Induced sputum analysis
Asthma Control Questionnaire(ACQ)	2 years	sthma control was assessed by Asthma Control Questionnaire(ACQ)

Secondary Outcome Measures

Name	Time	Method
Prognosis prediction of asthma with specific treatment regimen	2 years	Prognosis prediction of asthma with specific treatment regimen was based on different phenotypes and biomarkers

Trial Locations

Locations (1)

Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China