Taiwan Severe Asthma Biologic Registry

Taichung Veterans General Hospital500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Pulmonary Disease Asthma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Status of Asthma Control

Mean change in Asthma Control Test score after biologic initiation.

Time frame: 6 months

Status of Asthma exacerbations

Annual frequency of exacerbations after biologic initiation.

Time frame: 6 months

Reduction of daily oral corticosteriod dose

Percentage of daily oral corticosteroids dose reduction after biologic initiation.

Time frame: 6 months

Change of Pre-BD FEV1 (%pred)

Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)

Time frame: 6 months

Secondary Outcomes

Disease Prognosis

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.

Time frame: 6 months

Mortality

Define the mortality rate of the study cohort

Time frame: 6 months

Taiwan Severe Asthma Biologic Registry

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts