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

AstraZeneca

Status: Enrolling

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT06419413

D2287R00186

Details and patient eligibility

About

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

Enrollment: 355 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

355 participants in 4 patient groups

Cohort A

Description:

approximately 80 healthy participants

Cohort B

Description:

approximately 40 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

Description:

approximately 160 moderate to severe asthmatics on low or medium dose ICS-long acting β2 agonists (LABA), high dose ICS alone or in combination with LABA .

Cohort D

Description:

approximately 75 asthmatics with protocol defined asthma exacerbation.