Moderate-to-Severe AsthmaPRESENTNCT06422663
A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
An observational study of Moderate-to-Severe Asthma, run by AstraZeneca at 31 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 130 years
- Conditions the study is for
- Moderate-to-Severe Asthma
- How many people
- 500 participants
- Where
- 31 sitesChina
- Study dates
- 22 Mar 2024to 13 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Moderate-to-Severe Asthma Patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Research Site
Baoding
Research Site
Beijing
Research Site
Changsha
Research Site
Chengdu
Research Site
Chongqing
Research Site
Dingzhou
Research Site
Hangzhou
Research Site
Harbin
Research Site
Hefei
Research Site
Hohhot
Research Site
Jinan
Research Site
Kunming
Research Site
Liuzhou
Research Site
Lu'an
Research Site
Luzhou
Research Site
Nanchang
Research Site
Nanchong
Research Site
Qingdao
Research Site
Quanzhou
Research Site
Shanghai
Research Site
Shenzhen
Research Site
Tianjin
Research Site
Tiaobingshan
Research Site
Wenzhou
Research Site
Wuhan
Research Site
Xi'an
Research Site
Xiamen
Research Site
Yongzhou
Research Site
Zhangjiagang
Research Site
Zhengzhou
Research Site
Zigong
About this study
Official title: A Prospective, Observational, Multicentre 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.
Read the 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.
- Conditions
- Moderate-to-Severe Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-Severe Asthma | enroll 500 subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: week 0, week 12 and week 24.
Secondary outcomes (19)
The ACT(Asthma Control Test, The range of the total score can be from 5 to 25.) score at week 0, 12, 24
To describe ACT of overall patients and of uncontrolled patients at baseline after 24-week follow up.
Measured: week 0, week 12 and week 24
The proportion of controlled patients
To describe control status of overall patients and of uncontrolled patients at baseline after 24-week follow up.
Measured: week 0, week 12 and week 24
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.
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
The proportion of patients with low/medium/high-dose ICS at week 0,12 and 24 in overall patients and uncontrolled patients at baseline.
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
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.
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
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.
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
Among those uncontrolled treated with medium-dose ICS at week 0, the proportion of patients with high-dose ICS over week 24.
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
Among those uncontrolled treated with low/medium dose ICS at week 0, the proportion of patients with treatment pattern changes over week 24.
To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
Annualized rate of exacerbations at week 0 visit for previous 12 months and at week 24 visit for follow up period
To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
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.
To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
Lung function (pre-BD FEV1) at week 0, 12 and 24.
To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups.
Measured: week 0, week 12 and week 24
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.
To describe proportions of severe asthma among moderate-to-severe asthma patients.
Measured: week 0, week 12 and week 24
The bEOS level at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline.
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
Measured: week 0, week 12 and week 24
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.
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
Measured: week 0, week 12 and week 24
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.
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
Measured: week 0, week 12 and week 24
The proportion of patients with bEOS ≥150/µL at week 24 among patients with EOS < 150/µL at baseline.
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
Measured: week 0, week 12 and week 24
The proportion of patients with bEOS ≥300/µL at week 24 among patients with EOS < 300/µL at baseline.
To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA.
Measured: week 0, week 12 and week 24
Healthcare utilization at week 0, 12 and 24.
To describe healthcare utilization2 of moderate-to-severe asthma patients and to describe by asthma severity.
Measured: week 0, week 12 and week 24
Asthma-related medical cost: Total costs, including total hospital costs, total outpatient costs and total ER costs
To describe healthcare utilization2 of moderate-to-severe asthma patients and to describe by asthma severity.
Measured: week 0, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start22 Mar 2024
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate-to-Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422663
- Sponsor's protocol ID
- D2287R00198
- Acronym
- PRESENT
- Status last verified
- Sep 2026
- First submitted
- 19 Mar 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Yu L, He J, Jiang Y, Wang G, Feng X, Chen L, Huang K, Wu H, Zhen L, Cao J, Li Z, Qiu Z. Disease burden and eosinophilic phenotype in Chinese patients with moderate-to-severe asthma: Baseline analysis of a prospective, multicenter study (PRESENT). Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261475564. doi: 10.1177/17534666261475564. Epub 2026 Aug 14.
PubMed 42601061
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China
- ClinicalTrials.gov ID
- NCT06422663
- Acronym / sponsor ID
- PRESENT / D2287R00198
- Conditions
- Moderate-to-Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-Severe Asthma | – | –enroll 500 subjects |
Who may qualify
- Ages
- 12 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Moderate-to-Severe Asthma Patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
19 secondary outcomes
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
The proportion of controlled patients
Time frame: week 0, week 12 and week 24
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
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
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
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
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
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
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
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
Lung function (pre-BD FEV1) at week 0, 12 and 24.
Time frame: week 0, week 12 and week 24
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
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
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
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
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
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
Healthcare utilization at week 0, 12 and 24.
Time frame: week 0, week 12 and week 24
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 42601061Yu L, He J, Jiang Y, Wang G, Feng X, Chen L, Huang K, Wu H, Zhen L, Cao J, Li Z, Qiu Z. Disease burden and eosinophilic phenotype in Chinese patients with moderate-to-severe asthma: Baseline analysis of a prospective, multicenter study (PRESENT). Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261475564. doi: 10.1177/17534666261475564. Epub 2026 Aug 14.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-Severe Asthma, run by AstraZeneca at 31 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.