AsthmaPRESENTIINCT06605885
An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
An observational study of Asthma, run by AstraZeneca at 29 sites in China.
Trial summary
This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 202 participants
- Where
- 29 sitesChina
- Study dates
- 14 Nov 2024to 1 Sep 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Approximately 200 asthma patients will be enrolled in this study distributed among 50 sites in China.
Who may be able to join
- Chinese, Female or Male
- Age: no limitation
- Physician-confirmed asthma diagnosis with documented evidence of diagnosis or evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests).
- Participants or their legal guardians must be able to provide informed consent.
- Prescription of asthma biologics at enrolment.
Who cannot join
- Participation in an interventional study within the last 3 months.
- 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 with the usage of biologics, or may influence the results of the study, or the patient's ability to participate in the study
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Research Site
Beijing
Research Site
Changsha
Research Site
Chengdu
Research Site
Foshan
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Hefei
Research Site
Jinan
Research Site
Kunming
Research Site
Nanchang
Research Site
Nanjing
Research Site
Ningbo
Research Site
Qingdao
Research Site
Quanzhou
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shenzhen
Research Site
Shijiazhuang
Research Site
Suining
Research Site
Taiyuan
Research Site
Tianjin
Research Site
Ürümqi
Research Site
Wenzhou
Research Site
Wuhan
Research Site
Wuxi
Research Site
Xi'an
Research Site
Zhengzhou
Research Site
Zhuhai
About this study
This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.
Read the detailed description
This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.
Approximately 200 patients with a physician diagnosis of asthma and prescribed with asthma biologics at visit 1 will be enrolled in this study, distributed among 50 sites across different regions in China.
During the study period, patients will be identified consecutively and, if they meet eligibility criteria and provide informed consent will be entered into this observational study. Patients should have an asthma diagnosis and be prescribed at least once with biologics for asthma treatment at enrollment (Visit 1, Week 0).
After the enrollment, subjects will be followed up at Visit 2(Week 24) and Visit 3 (Week 52). V1, V2 and V3 will be followed up by on-site visit. At Visit 1, data within last 12 months will be retrospectively collected as baseline. Patients existing medical record (MR) data will be collected in week 24 and week 52. PROs (Asthma control test [ACT], Asthma Quality of Life Questionnaire (+12) [AQLQ(S)+12]) should be performed at Visit 1, Visit 2 and Visit 3.
No additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. Patients will not receive any experimental disease management intervention or experimental treatment as a result of their participation in the study.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of days covered (PDC) with asthma biologics during 52 weeks
to describe the persistence to asthma biologics using proportion of days covered (PDC) with asthma biologics during 52 weeks.
Measured: week52
Secondary outcomes (20)
Time from asthma onset to first biologic initiation(month)
To describe asthma biologics treatment features
Measured: week0
Duration (days) of treatment with different type of biologics.
To describe asthma biologics treatment features
Measured: week 52
Proportion of patients discontinued biologics in week 24 and week 52.
To describe asthma biologics treatment features
Measured: week24,week52
Proportion of participants switching to other biologics for asthma in week 24 and week 52.
To describe asthma biologics treatment features
Measured: week24,week52
Proportion of participants with concurrent used of multiple biologics in week 24 and week 52.
To describe asthma biologics treatment features
Measured: week24,week52
Proportion of different categories including anti-IL5, anti-IL5R, anti-IL4R, anti-IgE and anti-TSLP of biologics during 52 weeks
To describe asthma biologics treatment features
Measured: week 52
Proportion of patients experiencing asthma related hospitalizations during 52 weeks
To describe effect of biologics on healthcare care resource utilization (HCRU)
Measured: week 52
Cost of asthma related hospitalization during 52 weeks
To describe effect of biologics on healthcare care resource utilization (HCRU)
Measured: week 52
Days on asthma related sick leaves during 52 weeks
To describe effect of biologics on healthcare care resource utilization (HCRU)
Measured: week 52
Number of emergency visit during 52 weeks
To describe effect of biologics on healthcare care resource utilization (HCRU)
Measured: week 52
Annualized exacerbation rates over 52 weeks
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Measured: week 52
Change from baseline of FEV1 at week 24, 52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Measured: week0,week 24, week 52
Change from baseline of ACT score at week 24, 52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Measured: week0,week 24,week52
Change from baseline of AQLQ(S)+12 score at week 24, 52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Measured: week0,week24,week52
Change of proportion of patients with high-dosage ICS from baseline to week 24,52
To describe maintenance treatment change after biologic initiation in two subgroups
Measured: week0,week24,week52
Change of proportion of patients with maintenance OCS from baseline to week 24,52
To describe maintenance treatment change after biologic initiation in two subgroups
Measured: week0,week 24,Week 52
Proportion of days covered (PDC) with maintenance medication at baseline (in last 3 months)
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Measured: week0
Levels of bEOS at baseline
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Measured: week0
Levels of FeNO at baseline
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Measured: week0
Levels of IgE at baseline
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Measured: week0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start14 Nov 2024
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YuBiao Guo, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605885
- Sponsor's protocol ID
- D5180R00039
- Acronym
- PRESENTII
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2024
- Last updated
- 20 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
- ClinicalTrials.gov ID
- NCT06605885
- Acronym / sponsor ID
- PRESENTII / D5180R00039
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 20 Sep 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 study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.
Detailed description
This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.
Approximately 200 patients with a physician diagnosis of asthma and prescribed with asthma biologics at visit 1 will be enrolled in this study, distributed among 50 sites across different regions in China.
During the study period, patients will be identified consecutively and, if they meet eligibility criteria and provide informed consent will be entered into this observational study. Patients should have an asthma diagnosis and be prescribed at least once with biologics for asthma treatment at enrollment (Visit 1, Week 0).
After the enrollment, subjects will be followed up at Visit 2(Week 24) and Visit 3 (Week 52). V1, V2 and V3 will be followed up by on-site visit. At Visit 1, data within last 12 months will be retrospectively collected as baseline. Patients existing medical record (MR) data will be collected in week 24 and week 52. PROs (Asthma control test [ACT], Asthma Quality of Life Questionnaire (+12) [AQLQ(S)+12]) should be performed at Visit 1, Visit 2 and Visit 3.
No additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. Patients will not receive any experimental disease management intervention or experimental treatment as a result of their participation in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 200 asthma patients will be enrolled in this study distributed among 50 sites in China.
Key inclusion criteria (5 listed)
- Chinese, Female or Male
- Age: no limitation
- Physician-confirmed asthma diagnosis with documented evidence of diagnosis or evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests).
- Participants or their legal guardians must be able to provide informed consent.
- Prescription of asthma biologics at enrolment.
Key exclusion criteria (2 listed)
- Participation in an interventional study within the last 3 months.
- 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 with the usage of biologics, or may influence the results of the study, or the patient's ability to participate in the study
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
the proportion of days covered (PDC) with asthma biologics during 52 weeks
Time frame: week52
to describe the persistence to asthma biologics using proportion of days covered (PDC) with asthma biologics during 52 weeks.
20 secondary outcomes
Time from asthma onset to first biologic initiation(month)
Time frame: week0
Duration (days) of treatment with different type of biologics.
Time frame: week 52
Proportion of patients discontinued biologics in week 24 and week 52.
Time frame: week24,week52
Proportion of participants switching to other biologics for asthma in week 24 and week 52.
Time frame: week24,week52
Proportion of participants with concurrent used of multiple biologics in week 24 and week 52.
Time frame: week24,week52
Proportion of different categories including anti-IL5, anti-IL5R, anti-IL4R, anti-IgE and anti-TSLP of biologics during 52 weeks
Time frame: week 52
Proportion of patients experiencing asthma related hospitalizations during 52 weeks
Time frame: week 52
Cost of asthma related hospitalization during 52 weeks
Time frame: week 52
Days on asthma related sick leaves during 52 weeks
Time frame: week 52
Number of emergency visit during 52 weeks
Time frame: week 52
Annualized exacerbation rates over 52 weeks
Time frame: week 52
Change from baseline of FEV1 at week 24, 52
Time frame: week0,week 24, week 52
Change from baseline of ACT score at week 24, 52
Time frame: week0,week 24,week52
Change from baseline of AQLQ(S)+12 score at week 24, 52
Time frame: week0,week24,week52
Change of proportion of patients with high-dosage ICS from baseline to week 24,52
Time frame: week0,week24,week52
Change of proportion of patients with maintenance OCS from baseline to week 24,52
Time frame: week0,week 24,Week 52
Proportion of days covered (PDC) with maintenance medication at baseline (in last 3 months)
Time frame: week0
Levels of bEOS at baseline
Time frame: week0
Levels of FeNO at baseline
Time frame: week0
Levels of IgE at baseline
Time frame: week0
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 20 Oct 2026.
- 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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Asthma
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.
YuBiao Guo principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 29 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 5 inclusion and 2 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
the proportion of days covered (PDC) with asthma biologics during 52 weeks (time frame: week52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.