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

Moderate-to-Severe Asthma Clinical Trial

— PRESENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422663
• Other study ID #: D2287R00198
• Status: Recruiting
• Start date: March 22, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Moderate-to-Severe Asthma

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of adverse events	To summarize the safety data, including frequency of adverse events	week 0, week 12 and week 24
Other	Percentage of adverse events.	To summarize the safety data, including percentage of adverse events.	week 0, week 12 and week 24
Other	Frequency of serious adverse events.	To summarize the safety data, including frequency of serious adverse events.	week 0, week 12 and week 24.
Other	Percentage of serious adverse events.	To summarize the safety data, including percentage of serious adverse events.	week 0, week 12 and week 24
Primary	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	To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China.	week 0, week 12 and week 24.
Secondary	Ashma disease burden: Exacerbation rate	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)	week 0, week 12 and week 24
Secondary	Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment	To describe the proportion of severe asthma among all patients according to GINA 2023 & CN 2020 guidelines	week 0, week 12 and week 24
Secondary	Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype	To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12&24	week 0, week 12 and week 24
Secondary	Asthma-related emergency visit.	To describe healthcare utilization by baseline asthma severity (moderate or severe)	week 0, week 12 and week 24
Secondary	Ashma disease burden: Asthma Control Test	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)	week 0, week 12 and week 24
Secondary	Ashma disease burden: Lung function (FEV1)	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)	week 0, week 12 and week 24
Secondary	Asthma disease burden: Treatment patterns	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)	week 0, week 12 and week 24
Secondary	Asthma-related outpatient visit.	To describe healthcare utilization by baseline asthma severity (moderate or severe)	week 0, week 12 and week 24
Secondary	Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use.	To describe healthcare utilization by baseline asthma severity (moderate or severe)	week 0, week 12 and week 24
Secondary	Asthma-related diagnostic tests (X-ray, CT scan, et al.)	To describe healthcare utilization by baseline asthma severity (moderate or severe)	week 0, week 12 and week 24