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

NCT06419413 · AstraZeneca
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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
About this study
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
Eligibility criteria
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 design
Enrollment target: 355 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-01-08
Estimated completion: 2026-10-08
Last updated: 2026-05-19
Primary outcomes
  • Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables. (At baseline)
  • Descriptive summary of biomarker level. (At baseline)
  • Statistical clustering of key biomarkers. (At baseline)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (21)
Research SiteRecruiting
Chengdu, Sichuan, China
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Beijing, China
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Changsha, China
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Dongguan, China
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Foshan, China
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Guangzhou, China
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Hainan, China
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Hohhot, China
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Huizhou, China
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Kunming, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Shenyang, China
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Taiyuan, China
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Wenzhou, China
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Wuhan, China
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Xi'an, China
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Xuzhou, China
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Zhanjiang, China
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Zhaoqing, China
A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population · TrialPath