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RecruitingNCT06419413Updated Aug 18, 2026

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

An observational study in Asthma, sponsored by AstraZeneca. Recruiting at 21 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by AstraZeneca · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
355
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Asthma

Browse trials for

03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 355 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
355 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline

  2. Descriptive summary of biomarker level.

    Descriptive summary of biomarker level at baseline by study cohorts.

    Time frame: At baseline

  3. Statistical clustering of key biomarkers.

    Statistical clustering of key biomarkers in moderate to severe asthma cohort.

    Time frame: At baseline

  4. FEV1 level

    Evaluation of lung function via airway limitation

    Time frame: At baseline

  5. Forced Vital Capacity (FVC)

    Evaluation of lung function via airway limitation

    Time frame: At baseline

  6. Maximal Mid Expiratory Flow (MMEF)

    Evaluation of lung function via airway limitation

    Time frame: At baseline

  7. Airway remodeling

    Evaluation of lung structure profile and change

    Time frame: At baseline

  8. Gas trapping

    Evaluation of lung structure profile and change

    Time frame: At baseline

  9. Computed Tomography (CT) Scan

    Evaluation of lung structure profile and change

    Time frame: At baseline

Secondary outcomes

  1. Mean difference in the biomarker level.

    Mean difference in the biomarker level between study cohorts

    Time frame: At baseline

  2. Statistical association between the biomarker and clinical disease outcomes.

    Statistical association between the biomarker and clinical disease outcomes in each asthma cohort.

    Time frame: From 2023-2025

  3. Mean difference in the biomarker level between different tissues

    Mean difference in the biomarker level between different tissues in each asthma cohort.

    Time frame: From 2023-2025

07

Study locations

4 of 21 sites recruiting
  • Research Site
    Chengdu, Sichuan, China
    Recruiting
  • Research Site
    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
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06419413
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Jan 8, 2024
Primary completion
Oct 8, 2026 (estimated)
Completion
Oct 8, 2026 (estimated)
Last update
Aug 18, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479
View the source record on ClinicalTrials.gov ↗

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