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

Recruiting

• Conditions: Asthma

• Registration Number: NCT06419413
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-10-08
• Study Completion: 2026-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhaoqing, China