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

NCT ID: NCT06419413

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-10-08

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

approximately 80 healthy participants

No interventions assigned to this group

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.

No interventions assigned to this group

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 .

No interventions assigned to this group

Cohort D

approximately 75 asthmatics with protocol defined asthma exacerbation.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Chengdu, Sichuan, China

Site Status RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Changsha, , China

Site Status NOT_YET_RECRUITING

Research Site

Dongguan, , China

Site Status NOT_YET_RECRUITING

Research Site

Foshan, , China

Site Status NOT_YET_RECRUITING

Research Site

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Hainan, , China

Site Status NOT_YET_RECRUITING

Research Site

Hohhot, , China

Site Status NOT_YET_RECRUITING

Research Site

Huizhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Kunming, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanjing, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanning, , China

Site Status NOT_YET_RECRUITING

Research Site

Shanghai, , China

Site Status NOT_YET_RECRUITING

Research Site

Shenyang, , China

Site Status NOT_YET_RECRUITING

Research Site

Taiyuan, , China

Site Status RECRUITING

Research Site

Wenzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Wuhan, , China

Site Status RECRUITING

Research Site

Xi'an, , China

Site Status RECRUITING

Research Site

Xuzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Zhanjiang, , China

Site Status NOT_YET_RECRUITING

Research Site

Zhaoqing, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D2287R00186

Identifier Type: -

Identifier Source: org_study_id

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