Taiwan Severe Asthma Biologic Registry (TARGET)

Taichung Veterans General Hospital

Status: Enrolling

Conditions: Asthma; Pulmonary Disease

Treatments: Biological: Biological Treatment for severe asthma patients

Study type: Observational

Funder types: Other

Identifiers

NCT06456450

CE24049B

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 5 patient groups

Omalizumab

Description:

Severe asthma patients who are treated with omalizumab after January 1, 2020.

Treatment:

Biological: Biological Treatment for severe asthma patients

Mepolizumab

Description:

Severe asthma patients who are treated with mepolizumab after January 1, 2020.

Treatment:

Biological: Biological Treatment for severe asthma patients

Benralizumab

Description:

Severe asthma patients who are treated with benralizumab after January 1, 2020.

Treatment:

Biological: Biological Treatment for severe asthma patients

Dupilzumab

Description:

Severe asthma patients who are treated with dupilzumab after January 1, 2020.

Treatment:

Biological: Biological Treatment for severe asthma patients

Tezepelumab

Description:

Severe asthma patients who are treated with Tezepelumab after January 1, 2020.

Treatment:

Biological: Biological Treatment for severe asthma patients