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

NCT ID: NCT06422663

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-22

Study Completion Date

2025-03-13

Brief Summary

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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

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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

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Moderate-to-Severe Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate-to-Severe Asthma

enroll 500 subjects

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Baoding, , China

Site Status

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Beijing, , China

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Changsha, , China

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Chengdu, , China

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Chongqing, , China

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Dingzhou, , China

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Hangzhou, , China

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Harbin, , China

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Hefei, , China

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Hohhot, , China

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Jinan, , China

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Kunming, , China

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Liuzhou, , China

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Lu'an, , China

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Luzhou, , China

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Nanchang, , China

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Nanchong, , China

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Qingdao, , China

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Quanzhou, , China

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Shanghai, , China

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Shenzhen, , China

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Tianjin, , China

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Tiaobingshan, , China

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Wenzhou, , China

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Wuhan, , China

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Xi'an, , China

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Xiamen, , China

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Yongzhou, , China

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Zhangjiagang, , China

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Zhengzhou, , China

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Zigong, , China

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Countries

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China

Other Identifiers

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D2287R00198

Identifier Type: -

Identifier Source: org_study_id

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