A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
PRESENT
A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
1 other identifier
observational
500
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Shorter than P25 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedStudy Start
First participant enrolled
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2025
CompletedApril 8, 2025
April 1, 2025
12 months
March 19, 2024
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Ashma disease burden: Exacerbation rate
week 0, week 12 and week 24
Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment
week 0, week 12 and week 24
Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype
week 0, week 12 and week 24
Asthma-related emergency visit.
week 0, week 12 and week 24
Ashma disease burden: Asthma Control Test
week 0, week 12 and week 24
- +5 more secondary outcomes
Other Outcomes (4)
Frequency of adverse events
week 0, week 12 and week 24
Percentage of adverse events.
week 0, week 12 and week 24
Frequency of serious adverse events.
week 0, week 12 and week 24.
- +1 more other outcomes
Study Arms (1)
Moderate-to-Severe Asthma
enroll 500 subjects
Eligibility Criteria
Moderate-to-Severe Asthma Patients
You may qualify if:
- Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests)
- Written informed consent
- Moderate-to-severe asthma (asthma patients with treatment of GINA Step 3-5)
- Age 12 years old and above
You may not qualify if:
- Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma
- 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.)
- 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
- Disease or condition other than asthma that requires treatment with systemic or oral steroids
- Patients with poor inhaler skills and adherence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Baoding, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dingzhou, China
Research Site
Hangzhou, China
Research Site
Harbin, China
Research Site
Hefei, China
Research Site
Hohhot, China
Research Site
Jinan, China
Research Site
Kunming, China
Research Site
Liuchow, China
Research Site
Lu'an, China
Research Site
Luzhou, China
Research Site
Nanchang, China
Research Site
Nanchong, China
Research Site
Qingdao, China
Research Site
Quanzhou, China
Research Site
Shanghai, China
Research Site
Shenzhen, China
Research Site
Tianjin, China
Research Site
Tiaobingshan, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Xi'an, China
Research Site
Xiamen, China
Research Site
Yongzhou, China
Research Site
Zhangjiagang, China
Research Site
Zhengzhou, China
Research Site
Zigong, China
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
May 21, 2024
Study Start
March 22, 2024
Primary Completion
March 13, 2025
Study Completion
March 13, 2025
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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/
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.