Taiwan Severe Asthma Biologic Registry (TARGET)

May 17, 2026 updated by: Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital

This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan.

The goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.

The main question[s] it aims to answer are:

  1. Determine risk factors associated with poor asthma control.
  2. Support the development of effectiveness and safety of therapeutic principles
  3. To discover the real-world effectiveness of different biologics ( Clinical remission)
  4. To discover the impact of initiating biologics for severe asthma patients.
  5. To evaluate the prevalence of biologics switching and its benefits for patients.
  6. To compare the achievement rate of clinical remission among different biologics.

Participants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Pin-Kuei Fu, MD.,PhD.
  • Phone Number: 6535 886-4-23592525
  • Email: yetquen@gmail.com

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Severe Asthma Patient

Description

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case.
  • Female and male aged over 18 years old.
  • Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020.

Exclusion Criteria:

  • Lack of informed consent for participation.
  • History of Biologic usage before January 1, 2020, should be ruled out.
  • The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation.
  • Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Omalizumab
Severe asthma patients who are treated with omalizumab after January 1, 2020.
Biological: Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Other Names:
  • Tezepelumab
  • Omalizumab
  • Benralizumab
  • Mepolizumab
  • Dupilzumab
Mepolizumab
Severe asthma patients who are treated with mepolizumab after January 1, 2020.
Biological: Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Other Names:
  • Tezepelumab
  • Omalizumab
  • Benralizumab
  • Mepolizumab
  • Dupilzumab
Benralizumab
Severe asthma patients who are treated with benralizumab after January 1, 2020.
Biological: Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Other Names:
  • Tezepelumab
  • Omalizumab
  • Benralizumab
  • Mepolizumab
  • Dupilzumab
Dupilzumab
Severe asthma patients who are treated with dupilzumab after January 1, 2020.
Biological: Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Other Names:
  • Tezepelumab
  • Omalizumab
  • Benralizumab
  • Mepolizumab
  • Dupilzumab
Tezepelumab
Severe asthma patients who are treated with Tezepelumab after January 1, 2020.
Biological: Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Other Names:
  • Tezepelumab
  • Omalizumab
  • Benralizumab
  • Mepolizumab
  • Dupilzumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Status of Asthma Control
Time Frame: 6 months
Mean change in Asthma Control Test score after biologic initiation.
6 months
Status of Asthma exacerbations
Time Frame: 6 months
Annual frequency of exacerbations after biologic initiation.
6 months
Reduction of daily oral corticosteriod dose
Time Frame: 6 months
Percentage of daily oral corticosteroids dose reduction after biologic initiation.
6 months
Change of Pre-BD FEV1 (%pred)
Time Frame: 6 months
Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Prognosis
Time Frame: 6 months
  1. Describe the Cross-sectional phenotypic or pathophysiological (endotype) characteristics of poor asthma control.
  2. Describe the natural history, intervention responsiveness and long-term prognosis of severe asthma.
6 months
Mortality
Time Frame: 6 months
Define the mortality rate of the study cohort
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taichung Veterans General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chang Gung Memorial Hospital
National Cheng-Kung University Hospital
E-DA Hospital
National Yang Ming Chiao Tung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2043

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2043

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE24049B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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