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

Completed

• Conditions: Moderate-to-Severe Asthma

• Registration Number: NCT06422663
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2024-03-19
• Study Start: 2024-03-22
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Primary Completion: 2025-03-13
• Study Completion: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	week 0, week 12 and week 24.	To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China.

Secondary Outcome Measures

Name	Time	Method
Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment	week 0, week 12 and week 24	To describe the proportion of severe asthma among all patients according to GINA 2023 \& CN 2020 guidelines
Asthma-related emergency visit.	week 0, week 12 and week 24	To describe healthcare utilization by baseline asthma severity (moderate or severe)
Asthma disease burden: Treatment patterns	week 0, week 12 and week 24	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)
Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use.	week 0, week 12 and week 24	To describe healthcare utilization by baseline asthma severity (moderate or severe)
Ashma disease burden: Asthma Control Test	week 0, week 12 and week 24	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)
Ashma disease burden: Exacerbation rate	week 0, week 12 and week 24	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)
Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype	week 0, week 12 and week 24	To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12\&24
Asthma-related outpatient visit.	week 0, week 12 and week 24	To describe healthcare utilization by baseline asthma severity (moderate or severe)
Ashma disease burden: Lung function (FEV1)	week 0, week 12 and week 24	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)
Asthma-related diagnostic tests (X-ray, CT scan, et al.)	week 0, week 12 and week 24	To describe healthcare utilization by baseline asthma severity (moderate or severe)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zigong, China