Clinical trial NCT06419413: A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of up to 800 participants (males and females aged 18 to 75 years) will be recruited and enrolled into 4 cohorts:Cohort A: up to 100 healthy participants, with pre-bronchodilator Forced expiratory volume in 1 second (FEV1) ≥80% predicted. Partial healthy participants in Cohort A will also serve as the external healthy control group in the chronic obstructive pulmonary disease (COPD) translational study (D2287R00187, sponsored by AstraZeneca).

Cohort B: up to 200 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 300 moderate to severe asthmatics on low or medium dose ICS-long acting β2 agonists (LABA), high dose ICS alone or in combination with LABA with pre-bronchodilator FEV1 \<80% predicted.

Cohort D: up to 200 asthmatics with protocol defined asthma exacerbation.

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables.
timeFrame: At baseline
measure: Descriptive summary of biomarker level.
timeFrame: At baseline
measure: Statistical clustering of key biomarkers.
timeFrame: At baseline
measure: FEV1 level
timeFrame: At baseline
measure: Forced Vital Capacity (FVC)
timeFrame: At baseline
measure: Maximal Mid Expiratory Flow (MMEF)
timeFrame: At baseline
measure: Airway remodeling
timeFrame: At baseline
measure: Gas trapping
timeFrame: At baseline
measure: Computed Tomography (CT) Scan
timeFrame: At baseline
Secondary outcomes:
measure: Mean difference in the biomarker level.
timeFrame: At baseline
measure: Statistical association between the biomarker and clinical disease outcomes.
timeFrame: From 2023-2025
measure: Mean difference in the biomarker level between different tissues
timeFrame: From 2023-2025
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Dongguan
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hainan
country: China
facility: Research Site
city: Hohhot
country: China
facility: Research Site
city: Huizhou
country: China
facility: Research Site
city: Kunmin
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Zhanjiang
country: China
facility: Research Site
city: Zhaoqing
country: China
facility: Research Site
Study officials:
References: