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
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
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
A total of up to 355 participants will be recruited and enrolled into Cohort A (healthy participants), Cohort B (mild asthmatics), Cohort C (moderate to severe asthmatics), and Cohort D (Exacerbation asthmatics). Enrolment will be monitored to, 1) ensure at least 20 current smoker or ex-smoker in Cohort A; 2) ensure at least 40 male participants aged 40 years old or above in Cohort A.
Cohort
Prospective
Not listed
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.
Descriptive summary of biomarker level.
Descriptive summary of biomarker level at baseline by study cohorts.
Statistical clustering of key biomarkers.
Statistical clustering of key biomarkers in moderate to severe asthma cohort.
FEV1 level
Evaluation of lung function via airway limitation
Mean difference in the biomarker level.
Mean difference in the biomarker level between study cohorts
Statistical association between the biomarker and clinical disease outcomes.
Statistical association between the biomarker and clinical disease outcomes in each asthma cohort.
Mean difference in the biomarker level between different tissues
Mean difference in the biomarker level between different tissues in each asthma cohort.
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