Pulmonary DiseaseTARGETNCT06456450
Taiwan Severe Asthma Biologic Registry
An observational study of Pulmonary Disease and Asthma, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Asthma
- What is being tested?
- Biological Treatment for severe asthma patients
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Nov 2023to 28 Feb 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe Asthma Patient
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Pin-Kuei Fu, MD, PhD, 886-4-23592525 ext. 3213, yetquen@gmail.com
About this study
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.
Read more
The main question[s] it aims to answer are:
- Determine risk factors associated with poor asthma control.
- Support the development of effectiveness and safety of therapeutic principles
- To discover the real-world effectiveness of different biologics ( Clinical remission)
- To discover the impact of initiating biologics for severe asthma patients.
- To evaluate the prevalence of biologics switching and its benefits for patients.
- 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.
- Conditions
- Pulmonary Disease, Asthma
- Being tested
- Biological Treatment for severe asthma patients
- Keywords
- Severe Asthma, Registry, Biologic
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Treatment for severe asthma patientsBiological
Also called Omalizumab, Mepolizumab, Benralizumab, Dupilzumab
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Severe asthma patients who are treated with omalizumab after January 1, 2020. Receives: Biological: Biological Treatment for severe asthma patients | |
| Mepolizumab | Severe asthma patients who are treated with mepolizumab after January 1, 2020. Receives: Biological: Biological Treatment for severe asthma patients | |
| Benralizumab | Severe asthma patients who are treated with benralizumab after January 1, 2020. Receives: Biological: Biological Treatment for severe asthma patients | |
| Dupilzumab | Severe asthma patients who are treated with dupilzumab after January 1, 2020. Receives: Biological: Biological Treatment for severe asthma patients | |
| Tezepelumab | Severe asthma patients who are treated with Tezepelumab after January 1, 2020. Receives: Biological: Biological Treatment for severe asthma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of Asthma Control
Mean change in Asthma Control Test score after biologic initiation.
Measured: 6 months
Status of Asthma exacerbations
Annual frequency of exacerbations after biologic initiation.
Measured: 6 months
Reduction of daily oral corticosteriod dose
Percentage of daily oral corticosteroids dose reduction after biologic initiation.
Measured: 6 months
Change of Pre-BD FEV1 (%pred)
Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)
Measured: 6 months
Secondary outcomes (2)
Disease Prognosis
- Describe the Cross-sectional phenotypic or pathophysiological (endotype) characteristics of poor asthma control.
- Describe the natural history, intervention responsiveness and long-term prognosis of severe asthma.
Measured: 6 months
Mortality
Define the mortality rate of the study cohort
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start11 Nov 2023
- Primary completion28 Feb 2043 (estimated)
- Study completion28 Feb 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- E-DA Hospital, National Cheng-Kung University Hospital, National Yang Ming Chiao Tung University Hospital, Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456450
- Sponsor's protocol ID
- CE24049B
- Acronym
- TARGET
- Status last verified
- May 2026
- First submitted
- 30 May 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Severe Asthma Biologic Registry
- ClinicalTrials.gov ID
- NCT06456450
- Acronym / sponsor ID
- TARGET / CE24049B
- Conditions
- Pulmonary Disease, Asthma
- Keywords
- Severe Asthma, Registry, Biologic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- E-DA Hospital, National Cheng-Kung University Hospital, National Yang Ming Chiao Tung University Hospital, Chang Gung Memorial Hospital
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 28 Feb 2043 (estimated)
- Study completion
- 28 Feb 2043 (estimated)
- First posted
- 13 Jun 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 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:
- Determine risk factors associated with poor asthma control.
- Support the development of effectiveness and safety of therapeutic principles
- To discover the real-world effectiveness of different biologics ( Clinical remission)
- To discover the impact of initiating biologics for severe asthma patients.
- To evaluate the prevalence of biologics switching and its benefits for patients.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | – | Biological: Biological Treatment for severe asthma patientsSevere asthma patients who are treated with omalizumab after January 1, 2020. |
| Mepolizumab | – | Biological: Biological Treatment for severe asthma patientsSevere asthma patients who are treated with mepolizumab after January 1, 2020. |
| Benralizumab | – | Biological: Biological Treatment for severe asthma patientsSevere asthma patients who are treated with benralizumab after January 1, 2020. |
| Dupilzumab | – | Biological: Biological Treatment for severe asthma patientsSevere asthma patients who are treated with dupilzumab after January 1, 2020. |
| Tezepelumab | – | Biological: Biological Treatment for severe asthma patientsSevere asthma patients who are treated with Tezepelumab after January 1, 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe Asthma Patient
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological Treatment for severe asthma patientsAlso: Omalizumab, Mepolizumab, Benralizumab, DupilzumabBiological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance | Biological | Benralizumab, Dupilzumab, Mepolizumab, Omalizumab, Tezepelumab |
Primary outcome
Status of Asthma Control
Time frame: 6 months
Mean change in Asthma Control Test score after biologic initiation.
Status of Asthma exacerbations
Time frame: 6 months
Annual frequency of exacerbations after biologic initiation.
Reduction of daily oral corticosteriod dose
Time frame: 6 months
Percentage of daily oral corticosteroids dose reduction after biologic initiation.
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)
2 secondary outcomes
Disease Prognosis
Time frame: 6 months
Mortality
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Asthma, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 4 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pin-Kuei Fu, MD.,PhD. (886-4-23592525 ext. 6535, yetquen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of Asthma Control (time frame: 6 months). The study lists 4 primary outcomes in all. 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 19 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.