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NCT Number: NCT06605885

An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hohhot, China

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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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time from asthma onset to first biologic initiation(month)

    Time frame: week0

    To describe asthma biologics treatment features

  2. Duration (days) of treatment with different type of biologics.

    Time frame: week 52

    To describe asthma biologics treatment features

  3. Proportion of patients discontinued biologics in week 24 and week 52.

    Time frame: week24,week52

    To describe asthma biologics treatment features

  4. Proportion of participants switching to other biologics for asthma in week 24 and week 52.

    Time frame: week24,week52

    To describe asthma biologics treatment features

  5. Proportion of participants with concurrent used of multiple biologics in week 24 and week 52.

    Time frame: week24,week52

    To describe asthma biologics treatment features

  6. 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

    To describe asthma biologics treatment features

  7. Proportion of patients experiencing asthma related hospitalizations during 52 weeks

    Time frame: week 52

    To describe effect of biologics on healthcare care resource utilization (HCRU)

  8. Cost of asthma related hospitalization during 52 weeks

    Time frame: week 52

    To describe effect of biologics on healthcare care resource utilization (HCRU)

  9. Days on asthma related sick leaves during 52 weeks

    Time frame: week 52

    To describe effect of biologics on healthcare care resource utilization (HCRU)

  10. Number of emergency visit during 52 weeks

    Time frame: week 52

    To describe effect of biologics on healthcare care resource utilization (HCRU)

  11. Annualized exacerbation rates over 52 weeks

    Time frame: week 52

    To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups

  12. Change from baseline of FEV1 at week 24, 52

    Time frame: week0,week 24, week 52

    To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups

  13. Change from baseline of ACT score at week 24, 52

    Time frame: week0,week 24,week52

    To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups

  14. Change from baseline of AQLQ(S)+12 score at week 24, 52

    Time frame: week0,week24,week52

    To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups

  15. Change of proportion of patients with high-dosage ICS from baseline to week 24,52

    Time frame: week0,week24,week52

    To describe maintenance treatment change after biologic initiation in two subgroups

  16. Change of proportion of patients with maintenance OCS from baseline to week 24,52

    Time frame: week0,week 24,Week 52

    To describe maintenance treatment change after biologic initiation in two subgroups

  17. Proportion of days covered (PDC) with maintenance medication at baseline (in last 3 months)

    Time frame: week0

    To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups

  18. Levels of bEOS at baseline

    Time frame: week0

    To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups

  19. Levels of FeNO at baseline

    Time frame: week0

    To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups

  20. Levels of IgE at baseline

    Time frame: week0

    To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups

Other outcomes

  1. Proportion of different reasons for biologics discontinuation

    Time frame: week52

    To describe reasons for biologic discontinuation and switching, including asthma control, adverse event, cost or other more reasons.

  2. Proportion of different reasons for biologics switching

    Time frame: week52

    To describe reasons for biologic discontinuation and switching, including asthma control, adverse event, cost or other more reasons.

  3. Incidence of all AEs and SAEs

    Time frame: week52

    To describe reasons for biologic discontinuation and switching, including asthma control, adverse event, cost or other more reasons.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: PRESENTII

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 20, 2024
Registry last updated
May 6, 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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