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

N/ARecruitingNCT06419413

AstraZeneca355 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

355

Conditions

Asthma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (21)

Research Site

Chengdu, Sichuan, China

RECRUITING

Research Site

Beijing, China

Outcomes

Primary Outcomes

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

Descriptive summary of biomarker level.

Descriptive summary of biomarker level at baseline by study cohorts.

Time frame: At baseline

Statistical clustering of key biomarkers.

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

Time frame: At baseline

FEV1 level

Evaluation of lung function via airway limitation

Time frame: At baseline

Forced Vital Capacity (FVC)

Evaluation of lung function via airway limitation

Time frame: At baseline

Maximal Mid Expiratory Flow (MMEF)

Evaluation of lung function via airway limitation

Time frame: At baseline

Airway remodeling

Evaluation of lung structure profile and change

Time frame: At baseline

Gas trapping

Evaluation of lung structure profile and change

Time frame: At baseline

Computed Tomography (CT) Scan

Evaluation of lung structure profile and change

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Overview

Conditions

Eligibility

Locations (21)

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes