## Protocol Section
### Identification Module
**NCT ID:** NCT06419413

**Brief Title:** 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

#### Organization Study ID Info
**ID:** D2287R00186
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2026-10-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-10-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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

### Conditions Module

**Conditions:**

- Asthma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** up to 100 healthy participants, non-smokers, non-asthmatic with pre-bronchodilator Forced expiratory volume in 1 second (FEV1) ≥80% predicted.

**Label:** Cohort A

#### Arm Group 2

**Description:** 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.

**Label:** Cohort B

#### Arm Group 3

**Description:** 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.

**Label:** Cohort C

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables.

**Time Frame:** At baseline

**Description:** Descriptive summary of biomarker level at baseline by study cohorts.

**Measure:** Descriptive summary of biomarker level.

**Time Frame:** At baseline

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

**Measure:** Statistical clustering of key biomarkers.

**Time Frame:** At baseline

#### Secondary Outcomes

**Description:** Mean difference in the biomarker level between study cohorts

**Measure:** Mean difference in the biomarker level.

**Time Frame:** At baseline

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

**Measure:** Statistical association between the biomarker and clinical disease outcomes.

**Time Frame:** From 2023-2025

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

**Measure:** Mean difference in the biomarker level between different tissues

**Time Frame:** From 2023-2025

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** information.center@astrazeneca.com

**Name:** AstraZeneca Clinical Study Information Center

**Phone:** 1-877-240-9479

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chengdu

**Country:** China

**Facility:** Research Site

**State:** Sichuan

**Status:** RECRUITING

**Location 2:**

**City:** Beijing

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 3:**

**City:** Changsha

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 4:**

**City:** Dongguan

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 5:**

**City:** Foshan

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 6:**

**City:** Guangzhou

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 7:**

**City:** Hainan

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 8:**

**City:** Hohhot

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 9:**

**City:** Huizhou

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 10:**

**City:** Kunmin

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 11:**

**City:** Nanjing

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 12:**

**City:** Nanning

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 13:**

**City:** Shanghai

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 14:**

**City:** Shenyang

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 15:**

**City:** Taiyuan

**Country:** China

**Facility:** Research Site

**Status:** RECRUITING

**Location 16:**

**City:** Wenzhou

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 17:**

**City:** Wuhan

**Country:** China

**Facility:** Research Site

**Status:** RECRUITING

**Location 18:**

**City:** Xi'an

**Country:** China

**Facility:** Research Site

**Status:** RECRUITING

**Location 19:**

**City:** Xuzhou

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 20:**

**City:** Zhanjiang

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

**Location 21:**

**City:** Zhaoqing

**Country:** China

**Facility:** Research Site

**Status:** NOT_YET_RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Intervention Browse Module - Browse Branches

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M304

- Name: Formoterol Fumarate

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
