Taiwan Severe Asthma Biologic Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Severe Asthma Patient
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biological Treatment for severe asthma patients
Biological/VaccineBiological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance
Treatment groups
500 Participants
are divided into 5 treatment groupsGroup A: Omalizumab1 intervention
Group B: Mepolizumab1 intervention
Group C: Benralizumab1 intervention
Group D: Dupilzumab1 intervention
Group E: Tezepelumab1 intervention
Trial outcomes
Primary outcomes
1
Status of Asthma Control
Mean change in Asthma Control Test score after biologic initiation.
Time frame
6 months2
Status of Asthma exacerbations
Annual frequency of exacerbations after biologic initiation.
Time frame
6 months3
Reduction of daily oral corticosteriod dose
Percentage of daily oral corticosteroids dose reduction after biologic initiation.
Time frame
6 months4
Change of Pre-BD FEV1 (%pred)
Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)
Time frame
6 monthsSecondary outcomes
1
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 months2
Mortality
Define the mortality rate of the study cohort
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Taichung Veterans General Hospital
Lead sponsor
E-DA Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
National Yang Ming Chiao Tung University Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
Source ClinicalTrials.gov