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NCT Number: NCT06419413

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Chengdu, Sichuan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables.

    Time frame: At baseline

    Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables at baseline by study cohorts.

  2. Descriptive summary of biomarker level.

    Time frame: At baseline

    Descriptive summary of biomarker level at baseline by study cohorts.

  3. Statistical clustering of key biomarkers.

    Time frame: At baseline

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

  4. FEV1 level

    Time frame: At baseline

    Evaluation of lung function via airway limitation

  5. Forced Vital Capacity (FVC)

    Time frame: At baseline

    Evaluation of lung function via airway limitation

  6. Maximal Mid Expiratory Flow (MMEF)

    Time frame: At baseline

    Evaluation of lung function via airway limitation

  7. Airway remodeling

    Time frame: At baseline

    Evaluation of lung structure profile and change

  8. Gas trapping

    Time frame: At baseline

    Evaluation of lung structure profile and change

  9. Computed Tomography (CT) Scan

    Time frame: At baseline

    Evaluation of lung structure profile and change

Secondary outcomes

  1. Mean difference in the biomarker level.

    Time frame: At baseline

    Mean difference in the biomarker level between study cohorts

  2. Statistical association between the biomarker and clinical disease outcomes.

    Time frame: From 2023-2025

    Statistical association between the biomarker and clinical disease outcomes in each asthma cohort.

  3. Mean difference in the biomarker level between different tissues

    Time frame: From 2023-2025

    Mean difference in the biomarker level between different tissues in each asthma cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 17, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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