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NCT06419413 Clinical Trial

A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population

Asthma Clinical Trial

Official title:
A Transnational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06419413
Other study ID # D2287R00186
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 18, 2024
Est. completion date October 20, 2026

Study information
Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A Translational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes associated with Differential Outcomes that may Support Future Development of Personalised Treatment Strategies in Chinese Population

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date October 20, 2026
Est. primary completion date October 20, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age 18 to 75 years of age - acceptable FEV1 (according to ATS and ERS) - compliance with study procedures All Asthma Cohorts - physician diagnosed Asthma greater or equal to 3 months prior to screening visit Exclusion Criteria: - history of alcohol or drug abuse within the past year - pregnant at time of an assessment - has an altered mental status at the time of informed consent - receipt marketed or investigational biologic(s) within 3 months or 5 half-lives prior to visit 1, whichever is longer - history or current upper or lower respiratory infection or symptoms within 2 weeks of baseline assessments - terminal diseases and/or organ failure or participants otherwise considered not appropriate for the study participation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Research Site Beijing
China Research Site Changsha
China Research Site Chengdu Sichuan
China Research Site Dongguan
China Research Site Foshan
China Research Site Guangzhou
China Research Site Hainan
China Research Site Hohhot
China Research Site Huizhou
China Research Site Kunmin
China Research Site Nanjing
China Research Site Nanning
China Research Site Shanghai
China Research Site Shenyang
China Research Site Taiyuan
China Research Site Wenzhou
China Research Site Wuhan
China Research Site Xi'an
China Research Site Xuzhou
China Research Site Zhanjiang
China Research Site Zhaoqing

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables. Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables at baseline by study cohorts. At baseline
Primary Descriptive summary of biomarker level. Descriptive summary of biomarker level at baseline by study cohorts. At baseline
Primary Statistical clustering of key biomarkers. Statistical clustering of key biomarkers in moderate to severe asthma cohort. At baseline
Secondary Mean difference in the biomarker level. Mean difference in the biomarker level between study cohorts At baseline
Secondary Statistical association between the biomarker and clinical disease outcomes. Statistical association between the biomarker and clinical disease outcomes in each asthma cohort. From 2023-2025
Secondary Mean difference in the biomarker level between different tissues Mean difference in the biomarker level between different tissues in each asthma cohort. From 2023-2025
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