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

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

Study Overview

• Status: Recruiting
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Research Site
  • Changsha, China
    • Not yet recruiting
    • Research Site
  • Dongguan, China
    • Not yet recruiting
    • Research Site
  • Foshan, China
    • Not yet recruiting
    • Research Site
  • Guangzhou, China
    • Not yet recruiting
    • Research Site
  • Hainan, China
    • Not yet recruiting
    • Research Site
  • Hohhot, China
    • Not yet recruiting
    • Research Site
  • Huizhou, China
    • Not yet recruiting
    • Research Site
  • Kunmin, China
    • Not yet recruiting
    • Research Site
  • Nanjing, China
    • Not yet recruiting
    • Research Site
  • Nanning, China
    • Not yet recruiting
    • Research Site
  • Shanghai, China
    • Not yet recruiting
    • Research Site
  • Shenyang, China
    • Not yet recruiting
    • Research Site
  • Taiyuan, China
    • Recruiting
    • Research Site
  • Wenzhou, China
    • Not yet recruiting
    • Research Site
  • Wuhan, China
    • Recruiting
    • Research Site
  • Xi'an, China
    • Recruiting
    • Research Site
  • Xuzhou, China
    • Not yet recruiting
    • Research Site
  • Zhanjiang, China
    • Not yet recruiting
    • Research Site
  • Zhaoqing, China
    • Not yet recruiting
    • Research Site
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A total of up to 1000 participants will be recruited and enrolled into Cohort A (healthy participants), Cohort B (mild asthmatics), and Cohort C (moderate to severe asthmatics).

Enrollment will be monitored to, 1) ensure that no less than 30% of the study population in both Cohort B and Cohort C will be asthmatics with asthma onset before the age of 25 years (include 25 years); 2) ensure that at most 25% of participants who in both Cohort B and Cohort are current smokers or ex-smokers with a total smoking history of ≥10 pack years (not applicable for e-cigarettes); 3) ensure that at least 60% of participants in Cohort C have ACQ-5 ≥1.5; 4) ensure that no less than 30% of participants in Cohort C have severe asthma

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort A; up to 100 healthy participants, non-smokers, non-asthmatic with pre-bronchodilator Forced expiratory volume in 1 second (FEV1) ≥80% predicted.
Cohort B; up to 300 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; up to 600 moderate to severe asthmatics on low or medium dose ICS-long acting β2 agonists (LABA), high dose alone or in combination with LABA with pre-bronchodilator FEV1 < 80% predicted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline
Descriptive summary of biomarker level.	Descriptive summary of biomarker level at baseline by study cohorts.	At baseline
Statistical clustering of key biomarkers.	Statistical clustering of key biomarkers in moderate to severe asthma cohort.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference in the biomarker level.	Mean difference in the biomarker level between study cohorts	At baseline
Statistical association between the biomarker and clinical disease outcomes.	Statistical association between the biomarker and clinical disease outcomes in each asthma cohort.	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.	From 2023-2025

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287R00186