Taiwan Severe Asthma Biologic Registry

Recruiting

• Conditions: Asthma; Pulmonary Disease
• Interventions: Biological: Biological Treatment for severe asthma patients

• Registration Number: NCT06456450
• Lead Sponsor: Taichung Veterans General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-11
• Study First Submitted: 2024-05-30
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Primary Completion: 2043-02-28
• Study Completion: 2043-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mepolizumab	Biological Treatment for severe asthma patients	Severe asthma patients who are treated with mepolizumab after January 1, 2020.
Dupilzumab	Biological Treatment for severe asthma patients	Severe asthma patients who are treated with dupilzumab after January 1, 2020.
Omalizumab	Biological Treatment for severe asthma patients	Severe asthma patients who are treated with omalizumab after January 1, 2020.
Benralizumab	Biological Treatment for severe asthma patients	Severe asthma patients who are treated with benralizumab after January 1, 2020.
Tezepelumab	Biological Treatment for severe asthma patients	Severe asthma patients who are treated with Tezepelumab after January 1, 2020.

Primary Outcome Measures

Name	Time	Method
Status of Asthma exacerbations	6 months	Annual frequency of exacerbations 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)
Status of Asthma Control	6 months	Mean change in Asthma Control Test score after biologic initiation.
Reduction of daily oral corticosteriod dose	6 months	Percentage of daily oral corticosteroids dose reduction after biologic initiation.

Secondary Outcome Measures

Name	Time	Method
Disease Prognosis	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.
Mortality	6 months	Define the mortality rate of the study cohort

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan