Clinical trial NCT05937334: The Cohort Study for Asthma in China
Official title: The Cohort Study for Asthma in China: an Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma, Bronchial
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Test(ACT)
timeFrame: 2 years
measure: Asthma Control Questionnaire(ACQ)
timeFrame: 2 years
measure: Induced sputum analysis
timeFrame: 2 years
Secondary outcomes:
measure: Prognosis prediction of asthma with specific treatment regimen
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Kewu Huang, M.D.
role: STUDY_DIRECTOR
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