A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population
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
1 other identifier
observational
355
1 country
21
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2024
CompletedFirst Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 8, 2026
May 19, 2026
May 1, 2026
2.8 years
April 25, 2024
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
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
Descriptive summary of biomarker level.
Descriptive summary of biomarker level at baseline by study cohorts.
At baseline
Statistical clustering of key biomarkers.
Statistical clustering of key biomarkers in moderate to severe asthma cohort.
At baseline
FEV1 level
Evaluation of lung function via airway limitation
At baseline
Forced Vital Capacity (FVC)
Evaluation of lung function via airway limitation
At baseline
Maximal Mid Expiratory Flow (MMEF)
Evaluation of lung function via airway limitation
At baseline
Airway remodeling
Evaluation of lung structure profile and change
At baseline
Gas trapping
Evaluation of lung structure profile and change
At baseline
Computed Tomography (CT) Scan
Evaluation of lung structure profile and change
At baseline
Secondary Outcomes (3)
Mean difference in the biomarker level.
At baseline
Statistical association between the biomarker and clinical disease outcomes.
From 2023-2025
Mean difference in the biomarker level between different tissues
From 2023-2025
Study Arms (4)
Cohort A
approximately 80 healthy participants
Cohort B
approximately 40 mild asthmatics on as-needed low dose inhaled corticosteroids (ICS)-formoterol, or low dose ICS plus as-needed short-acting β2 agonists (SABA), without the need for other controller medication.
Cohort C
approximately 160 moderate to severe asthmatics on low or medium dose ICS-long acting β2 agonists (LABA), high dose ICS alone or in combination with LABA .
Cohort D
approximately 75 asthmatics with protocol defined asthma exacerbation.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Chengdu, Sichuan, China
Research Site
Beijing, China
Research Site
Changsha, 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
Kunming, 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, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2024
First Posted
May 17, 2024
Study Start
January 8, 2024
Primary Completion (Estimated)
October 8, 2026
Study Completion (Estimated)
October 8, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.