Taiwan Severe Asthma Biologic Registry

NCT06456450 · tracked via the Priya Life Science Taiwan tracker

Sponsor

Taichung Veterans General Hospital

Phase

Observational

Started

2023-11-11

Last updated

2026-05-19

Condition(s) studied

Pulmonary DiseaseAsthma

Investigational drug(s) / intervention(s)

Biological Treatment for severe asthma patients →

Biological Treatment for severe asthma patients: Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance

Study 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Taichung Veterans General Hospital	Taichung	Taiwan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06456450 on ClinicalTrials.gov ↗ ← All trials in Taiwan