A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Primary outcome measures
- Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables. [Time frame: At baseline]
- Descriptive summary of biomarker level. [Time frame: At baseline]
- Statistical clustering of key biomarkers. [Time frame: At baseline]
- FEV1 level [Time frame: At baseline]
- Forced Vital Capacity (FVC) [Time frame: At baseline]
- Maximal Mid Expiratory Flow (MMEF) [Time frame: At baseline]
- Airway remodeling [Time frame: At baseline]
- Gas trapping [Time frame: At baseline]
- Computed Tomography (CT) Scan [Time frame: At baseline]
Secondary outcome measures (3)
- Mean difference in the biomarker level. [Time frame: At baseline]
- Statistical association between the biomarker and clinical disease outcomes. [Time frame: From 2023-2025]
- Mean difference in the biomarker level between different tissues [Time frame: From 2023-2025]
Eligibility criteria
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
- Receipt LTRAs or 5-lipoxygenase (5-LO) inhibitors (eg zileuton and montelukast) within 1 month or 5 half-lives prior to baseline, whichever is longer.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 21 centers
- Research Site — Chengdu
- Research Site — Beijing
- Research Site — Changsha
- Research Site — Dongguan
- Research Site — Foshan
- Research Site — Guangzhou
- Research Site — Hainan
- Research Site — Hohhot
- … and 13 more centers
Identifiers
NCT: NCT06419413 · D2287R00186