Taiwan Severe Asthma Biologic Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological Treatment for severe asthma patients.
- Who it may be relevant to
- Registry conditions: Pulmonary Disease, Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Biological Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Primary outcome measures
- Status of Asthma Control [Time frame: 6 months]
- Status of Asthma exacerbations [Time frame: 6 months]
- Reduction of daily oral corticosteriod dose [Time frame: 6 months]
- Change of Pre-BD FEV1 (%pred) [Time frame: 6 months]
Secondary outcome measures (2)
- Disease Prognosis [Time frame: 6 months]
- Mortality [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Taichung Veterans General Hospital — Taichung
Identifiers
NCT: NCT06456450 · CE24049B