## Protocol Section
### Identification Module
**NCT ID:** NCT06422663

**Acronym:** PRESENT

**Brief Title:** A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China

**Official Title:** A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China

#### Organization Study ID Info
**ID:** D2287R00198
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2025-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a Prospective, Observational, Multicentre Study to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. Sponsor by Astrazeneca Investment(China) Co., LTD.

**Detailed Description:** This is a prospective, observational, multicentre study. Approximately 500 moderate-to-severe asthma patients from 30 sites across China. Patients will be treated following routine clinical practice. Study measures will be collected at week 0, week 12 and week 24.

The primary objective of PRESENT study is to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China.

### Conditions Module

**Conditions:**

- Moderate-to-Severe Asthma

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** enroll 500 subjects

**Label:** Moderate-to-Severe Asthma

### Outcomes Module

#### Other Outcomes

**Description:** To summarize the safety data, including frequency of adverse events

**Measure:** Frequency of adverse events

**Time Frame:** week 0, week 12 and week 24

**Description:** To summarize the safety data, including percentage of adverse events.

**Measure:** Percentage of adverse events.

**Time Frame:** week 0, week 12 and week 24

**Description:** To summarize the safety data, including frequency of serious adverse events.

**Measure:** Frequency of serious adverse events.

**Time Frame:** week 0, week 12 and week 24.

**Description:** To summarize the safety data, including percentage of serious adverse events.

**Measure:** Percentage of serious adverse events.

**Time Frame:** week 0, week 12 and week 24

#### Primary Outcomes

**Description:** To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China.

**Measure:** Proportion of uncontrolled patients with treatment modification, which is indicated by maintenance drug dosage change, switch, add-on, discontinue from week 0 to week 24

**Time Frame:** week 0, week 12 and week 24.

#### Secondary Outcomes

**Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

**Measure:** Ashma disease burden: Exacerbation rate

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe the proportion of severe asthma among all patients according to GINA 2023 \& CN 2020 guidelines

**Measure:** Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12\&24

**Measure:** Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe)

**Measure:** Asthma-related emergency visit.

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

**Measure:** Ashma disease burden: Asthma Control Test

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

**Measure:** Ashma disease burden: Lung function (FEV1)

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

**Measure:** Asthma disease burden: Treatment patterns

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe)

**Measure:** Asthma-related outpatient visit.

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe)

**Measure:** Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use.

**Time Frame:** week 0, week 12 and week 24

**Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe)

**Measure:** Asthma-related diagnostic tests (X-ray, CT scan, et al.)

**Time Frame:** week 0, week 12 and week 24

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests)
2. Written informed consent
3. Moderate-to-severe asthma (asthma patients with treatment of GINA Step 3-5)
4. Age 12 years old and above

Exclusion Criteria:

1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma
2. Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrolment. (Once enrolled in the PRESENT Study, patients should not enrol in any investigational trials.)
3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
4. Disease or condition other than asthma that requires treatment with systemic or oral steroids
5. Patients with poor inhaler skills and adherence

**Maximum Age:** 130 Years

**Minimum Age:** 12 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Moderate-to-Severe Asthma Patients

### 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:** Shanghai

**Country:** China

**Facility:** Shanghai Tongji Hospital

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 20000

### IPD Sharing Statement Module

**Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

URL: https://vivli.org/

**Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

**IPD Sharing:** YES

**Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

**URL:** https://vivli.org/

## 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

### Misc Info Module

- Version Holder: 2024-05-31
