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Completed
NCT Number: NCT06422663
A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
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.
Completed
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Conditions
Age range
12 year–130 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Research Site, Baoding, China
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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, which is defined as asthma patients with maintenance. treatment of GINA Step 3-5.
- Age 12 years old and above
Exclusion criteria
- 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
Treatment and study plan
Primary outcomes
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Among those uncontrolled patients treated with low/medium-dose ICS/LABA at week 0, the proportion of patients escalate to high dose ICS/LABA and still uncontrolled over 24 weeks.
Time frame: week 0, week 12 and week 24.
To describe the proportion of uncontrolled patients treated with low/medium-dose ICS/LABA escalated to high dose and fulfil the diagnosis of severe asthma.
Secondary outcomes
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The ACT(Asthma Control Test, The range of the total score can be from 5 to 25.) score at week 0, 12, 24
Time frame: week 0, week 12 and week 24
To describe ACT of overall patients and of uncontrolled patients at baseline after 24-week follow up.
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The proportion of controlled patients
Time frame: week 0, week 12 and week 24
To describe control status of overall patients and of uncontrolled patients at baseline after 24-week follow up.
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The distribution of patients in different treatment pattern at week 0 and week 24. Treatment pattern includes: ICS, LABA, LAMA, SAMA, SABA, OCS, LTAR, Theophylline, biologics, macrolide antibiotics, ICS+LABA, LAMA+LABA, ICS+LABA+LAMA and other.
Time frame: week 0, week 12 and week 24
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
-
The proportion of patients with low/medium/high-dose ICS at week 0,12 and 24 in overall patients and uncontrolled patients at baseline.
Time frame: week 0, week 12 and week 24
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
-
The proportion of patients use maintenance dosage of OCS (prednisolone 40-50 mg/day or equivalent prednisone, continuously use ≥3 days) at week 0, 12 and 24 in overall patients and uncontrolled patients at baseline.
Time frame: week 0, week 12 and week 24
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
-
Among those uncontrolled treated with low-dose ICS at week 0, the proportion of uncontrolled patients with medium -dose ICS and patients with high-dose ICS over week 24.
Time frame: week 0, week 12 and week 24
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
-
Among those uncontrolled treated with medium-dose ICS at week 0, the proportion of patients with high-dose ICS over week 24.
Time frame: week 0, week 12 and week 24
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
-
Among those uncontrolled treated with low/medium dose ICS at week 0, the proportion of patients with treatment pattern changes over week 24.
Time frame: week 0, week 12 and week 24
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
-
Annualized rate of exacerbations at week 0 visit for previous 12 months and at week 24 visit for follow up period
Time frame: week 0, week 12 and week 24
To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups.
-
ACT(Asthma Control Test)-related control status at week 0, 12 and 24. ACT scores of 20 to 25 denote well-controlled asthma, ACT scores ≤19 identifies patients with poorly controlled asthma.
Time frame: week 0, week 12 and week 24
To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups.
-
Lung function (pre-BD FEV1) at week 0, 12 and 24.
Time frame: week 0, week 12 and week 24
To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups.
-
Proportion of severe asthma among all patients according to GINA 2023, CN 2020 guideline and study defined severe asthma at week 0, 12 and 24 visit.
Time frame: week 0, week 12 and week 24
To describe proportions of severe asthma among moderate-to-severe asthma patients.
-
The bEOS level at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline.
Time frame: week 0, week 12 and week 24
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
-
The proportion of stratification of bEOS (EOS<150/µL, ≥150 to <300/µL, ≥300/µL) at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline.
Time frame: week 0, week 12 and week 24
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
-
The proportion of eosinophilic phenotype (eosinophilic asthma or not eosinophilic asthma) at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline.
Time frame: week 0, week 12 and week 24
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
-
The proportion of patients with bEOS ≥150/µL at week 24 among patients with EOS < 150/µL at baseline.
Time frame: week 0, week 12 and week 24
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
-
The proportion of patients with bEOS ≥300/µL at week 24 among patients with EOS < 300/µL at baseline.
Time frame: week 0, week 12 and week 24
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
-
Healthcare utilization at week 0, 12 and 24.
Time frame: week 0, week 12 and week 24
To describe healthcare utilization2 of moderate-to-severe asthma patients and to describe by asthma severity.
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Asthma-related medical cost: Total costs, including total hospital costs, total outpatient costs and total ER costs
Time frame: week 0, week 12 and week 24
To describe healthcare utilization2 of moderate-to-severe asthma patients and to describe by asthma severity.
Other outcomes
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Quality of life PRO EQ-5D(EuroQol-5D-5L) value as week 0 & 24 and subgroup analysis by severity at week 0 & 24 (moderate or severe by GINA guideline)
Time frame: week 0 and week 24
To describe quality of life of moderate-to-severe asthma patients.
-
Work productivity loss WPAI(Work Productivity and Activity Impairment Questionnaire) as week 0 & 24 and subgroup analysis by severity at week 0 & 24 (moderate or severe by GINA guideline)
Time frame: week 0 and week 24
To describe productivity loss of moderate-to-severe asthma patients
-
Frequency of serious adverse events.
Time frame: week 0, week 12 and week 24.
To summarize the safety data, including frequency of serious adverse events.
-
Percentage of serious adverse events.
Time frame: week 0, week 12 and week 24
To summarize the safety data, including percentage of serious adverse events.
-
Treatment adherence MARS-A(Medication Adherence Report Scale for Asthma) at week 0 & 24 and subgroup analysis by severity at week 0 & 24 (moderate or severe by GINA guideline)
Time frame: week 0 and week 24
To describe productivity loss of moderate-to-severe asthma patients
-
Frequency of adverse events.
Time frame: week 0, week 12 and week 24.
To summarize the safety data, including frequency of adverse events.
-
Percentage of adverse events.
Time frame: week 0, week 12 and week 24.
To summarize the safety data, including percentage of adverse events.
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Official study title
A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
Acronym: PRESENT
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- May 21, 2024
- Registry last updated
- Sep 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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