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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.

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Key information

Conditions

Moderate-to-Severe Asthma

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 (asthma patients with 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

  1. 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

    Time frame: week 0, week 12 and week 24.

    To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China.

Secondary outcomes

  1. Ashma disease burden: Exacerbation rate

    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. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

  2. Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment

    Time frame: week 0, week 12 and week 24

    To describe the proportion of severe asthma among all patients according to GINA 2023 & CN 2020 guidelines

  3. Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype

    Time frame: week 0, week 12 and week 24

    To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12&24

  4. Asthma-related emergency visit.

    Time frame: week 0, week 12 and week 24

    To describe healthcare utilization by baseline asthma severity (moderate or severe)

  5. Ashma disease burden: Asthma Control Test

    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. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

  6. Ashma disease burden: Lung function (FEV1)

    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. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

  7. Asthma disease burden: Treatment patterns

    Time frame: week 0, week 12 and week 24

    To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central)

  8. Asthma-related outpatient visit.

    Time frame: week 0, week 12 and week 24

    To describe healthcare utilization by baseline asthma severity (moderate or severe)

  9. Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use.

    Time frame: week 0, week 12 and week 24

    To describe healthcare utilization by baseline asthma severity (moderate or severe)

  10. Asthma-related diagnostic tests (X-ray, CT scan, et al.)

    Time frame: week 0, week 12 and week 24

    To describe healthcare utilization by baseline asthma severity (moderate or severe)

Other outcomes

  1. Frequency of adverse events

    Time frame: week 0, week 12 and week 24

    To summarize the safety data, including frequency of adverse events

  2. Percentage of adverse events.

    Time frame: week 0, week 12 and week 24

    To summarize the safety data, including percentage of adverse events.

  3. 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.

  4. 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.

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
Apr 8, 2025

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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