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

AstraZeneca

Status: Completed

Conditions: Moderate-to-Severe Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT06422663

D2287R00198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 12 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Moderate-to-Severe Asthma

Description:

enroll 500 subjects