A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes associated with Differential Outcomes in Chinese Population
Study identifier:D2287R00186
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Translational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and ndotypes associated with Differential Outcomes that may Support Future Development of Personalised Treatment Strategies in Chinese Population
Medical condition
asthma
Phase
N/A
Healthy volunteers
Yes
Study drug
-
Sex
All
Estimated Enrollment
1000
Study type
Observational
Age
18 Years - 75 Years
Date
Study Start Date: 18 Jan 2024
Estimated Primary Completion Date: 20 Oct 2026
Estimated Study Completion Date: 20 Oct 2026
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| 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. | - |
