AsthmaNCT06419413
A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population
An observational study of Asthma, run by AstraZeneca at 21 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 355 participants
- Where
- 21 sitesChina
- Study dates
- 8 Jan 2024to 8 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 1 country
China21 sites, 21 recruiting
- Not yet recruiting
Research Site
Beijing
- Not yet recruiting
Research Site
Changsha
- Recruiting
Research Site
Chengdu, Sichuan
- Not yet recruiting
Research Site
Dongguan
- Not yet recruiting
Research Site
Foshan
- Not yet recruiting
Research Site
Guangzhou
- Not yet recruiting
Research Site
Hainan
- Not yet recruiting
Research Site
Hohhot
- Not yet recruiting
Research Site
Huizhou
- Not yet recruiting
Research Site
Kunming
- Not yet recruiting
Research Site
Nanjing
- Not yet recruiting
Research Site
Nanning
- Not yet recruiting
Research Site
Shanghai
- Not yet recruiting
Research Site
Shenyang
- Recruiting
Research Site
Taiyuan
- Not yet recruiting
Research Site
Wenzhou
- Recruiting
Research Site
Wuhan
- Recruiting
Research Site
Xi'an
- Not yet recruiting
Research Site
Xuzhou
- Not yet recruiting
Research Site
Zhanjiang
- Not yet recruiting
Research Site
Zhaoqing
About this study
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
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
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Descriptive summary of biomarker level.
Descriptive summary of biomarker level at baseline by study cohorts.
Measured: At baseline
Statistical clustering of key biomarkers.
Statistical clustering of key biomarkers in moderate to severe asthma cohort.
Measured: At baseline
FEV1 level
Evaluation of lung function via airway limitation
Measured: At baseline
Forced Vital Capacity (FVC)
Evaluation of lung function via airway limitation
Measured: At baseline
Maximal Mid Expiratory Flow (MMEF)
Evaluation of lung function via airway limitation
Measured: At baseline
Airway remodeling
Evaluation of lung structure profile and change
Measured: At baseline
Gas trapping
Evaluation of lung structure profile and change
Measured: At baseline
Computed Tomography (CT) Scan
Evaluation of lung structure profile and change
Measured: At baseline
Secondary outcomes (3)
Mean difference in the biomarker level.
Mean difference in the biomarker level between study cohorts
Measured: At baseline
Statistical association between the biomarker and clinical disease outcomes.
Statistical association between the biomarker and clinical disease outcomes in each asthma cohort.
Measured: From 2023-2025
Mean difference in the biomarker level between different tissues
Mean difference in the biomarker level between different tissues in each asthma cohort.
Measured: From 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start8 Jan 2024
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419413
- Sponsor's protocol ID
- D2287R00186
- Status last verified
- Aug 2026
- First submitted
- 25 Apr 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Individual data sharing
- 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.