Clinical trial NCT06422663: A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
Official title: A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate-to-Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate-to-Severe Asthma Patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: week 0, week 12 and week 24.
Secondary outcomes:
measure: Ashma disease burden: Exacerbation rate
timeFrame: week 0, week 12 and week 24
measure: Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment
timeFrame: week 0, week 12 and week 24
measure: Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype
timeFrame: week 0, week 12 and week 24
measure: Asthma-related emergency visit.
timeFrame: week 0, week 12 and week 24
measure: Ashma disease burden: Asthma Control Test
timeFrame: week 0, week 12 and week 24
measure: Ashma disease burden: Lung function (FEV1)
timeFrame: week 0, week 12 and week 24
measure: Asthma disease burden: Treatment patterns
timeFrame: week 0, week 12 and week 24
measure: Asthma-related outpatient visit.
timeFrame: week 0, week 12 and week 24
measure: Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use.
timeFrame: week 0, week 12 and week 24
measure: Asthma-related diagnostic tests (X-ray, CT scan, et al.)
timeFrame: week 0, week 12 and week 24
Other outcomes:
measure: Frequency of adverse events
timeFrame: week 0, week 12 and week 24
measure: Percentage of adverse events.
timeFrame: week 0, week 12 and week 24
measure: Frequency of serious adverse events.
timeFrame: week 0, week 12 and week 24.
measure: Percentage of serious adverse events.
timeFrame: week 0, week 12 and week 24
Locations:
city: Baoding
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dingzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Hohhot
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Liuzhou
country: China
facility: Research Site
city: Lu An
country: China
facility: Research Site
city: Luzhou
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanchong
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Quanzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Tiaobingshan
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: XI An
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Yongzhou
country: China
facility: Research Site
city: Zhangjiagang
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zigong
country: China
facility: Research Site
Study officials:
References: