Recruiting

NCT Number: NCT05937334

The Cohort Study for Asthma in China

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.

Recruiting

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Key information

Conditions

Asthma, Bronchial Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic 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.

Primary outcomes

Asthma Control Test(ACT)

Time frame: 2 years

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

Time frame: 2 years

sthma control was assessed by Asthma Control Questionnaire(ACQ)
Induced sputum analysis

Time frame: 2 years

Identification of asthma endotypes was based on Induced sputum analysis

Secondary outcomes

Prognosis prediction of asthma with specific treatment regimen

Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Meishan Liu, M.D.

CONTACT

[email protected]

8613141403749

Ying Wang, M.D.

CONTACT

[email protected]

8613426121753

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2028
First posted: Jul 10, 2023
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed