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

May 18, 2026 updated by: AstraZeneca

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Research Site
      • Changsha, China
        • Not yet recruiting
        • Research Site
      • Dongguan, China
        • Not yet recruiting
        • Research Site
      • Foshan, China
        • Not yet recruiting
        • Research Site
      • Guangzhou, China
        • Not yet recruiting
        • Research Site
      • Hainan, China
        • Not yet recruiting
        • Research Site
      • Hohhot, China
        • Not yet recruiting
        • Research Site
      • Huizhou, China
        • Not yet recruiting
        • Research Site
      • Kunming, China
        • Not yet recruiting
        • Research Site
      • Nanjing, China
        • Not yet recruiting
        • Research Site
      • Nanning, China
        • Not yet recruiting
        • Research Site
      • Shanghai, China
        • Not yet recruiting
        • Research Site
      • Shenyang, China
        • Not yet recruiting
        • Research Site
      • Taiyuan, China
        • Recruiting
        • Research Site
      • Wenzhou, China
        • Not yet recruiting
        • Research Site
      • Wuhan, China
        • Recruiting
        • Research Site
      • Xi'an, China
        • Recruiting
        • Research Site
      • Xuzhou, China
        • Not yet recruiting
        • Research Site
      • Zhanjiang, China
        • Not yet recruiting
        • Research Site
      • Zhaoqing, China
        • Not yet recruiting
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables.
Time Frame: At baseline
Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables at baseline by study cohorts.
At baseline
Descriptive summary of biomarker level.
Time Frame: At baseline
Descriptive summary of biomarker level at baseline by study cohorts.
At baseline
Statistical clustering of key biomarkers.
Time Frame: At baseline
Statistical clustering of key biomarkers in moderate to severe asthma cohort.
At baseline
FEV1 level
Time Frame: At baseline
Evaluation of lung function via airway limitation
At baseline
Forced Vital Capacity (FVC)
Time Frame: At baseline
Evaluation of lung function via airway limitation
At baseline
Maximal Mid Expiratory Flow (MMEF)
Time Frame: At baseline
Evaluation of lung function via airway limitation
At baseline
Airway remodeling
Time Frame: At baseline
Evaluation of lung structure profile and change
At baseline
Gas trapping
Time Frame: At baseline
Evaluation of lung structure profile and change
At baseline
Computed Tomography (CT) Scan
Time Frame: At baseline
Evaluation of lung structure profile and change
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in the biomarker level.
Time Frame: At baseline
Mean difference in the biomarker level between study cohorts
At baseline
Statistical association between the biomarker and clinical disease outcomes.
Time Frame: From 2023-2025
Statistical association between the biomarker and clinical disease outcomes in each asthma cohort.
From 2023-2025
Mean difference in the biomarker level between different tissues
Time Frame: From 2023-2025
Mean difference in the biomarker level between different tissues in each asthma cohort.
From 2023-2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

October 8, 2026

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2287R00186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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