Taiwan Severe Asthma Biologic Registry (TARGET)

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: Recruiting
• Conditions: Asthma; Pulmonary Disease
• Intervention / Treatment: Biological: Biological Treatment for severe asthma patients

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: 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: Pin-Kuei Fu, MD, PhD; Phone Number: 3213 886-4-23592525; Email: yetquen@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Status of Asthma Control	Mean change in Asthma Control Test score after biologic initiation.	6 months
Status of Asthma exacerbations	Annual frequency of exacerbations after biologic initiation.	6 months
Reduction of daily oral corticosteriod dose	Percentage of daily oral corticosteroids dose reduction after biologic initiation.	6 months
Change of Pre-BD FEV1 (%pred)	Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Mortality	Define the mortality rate of the study cohort	6 months

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Collaborators: Chang Gung Memorial Hospital; National Cheng-Kung University Hospital; E-DA Hospital; National Yang Ming Chiao Tung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): February 28, 2043
• Study Completion (Estimated): February 28, 2043

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biologic; Registry; Severe Asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases; Asthma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Anti-Idiotypic; Omalizumab; mepolizumab; tezepelumab; benralizumab
• Other Study ID 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