Clinical trial NCT06456450: Taiwan Severe Asthma Biologic Registry
Official title: Taiwan Severe Asthma Biologic Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease
Asthma
Keywords: Severe Asthma
Registry
Biologic
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
name: National Cheng-Kung University Hospital
name: National Yang Ming Chiao Tung University Hospital
name: Chang Gung Memorial Hospital
First posted: 2024-06-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Asthma Patient

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.


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.

Primary outcomes:
measure: Status of Asthma Control
timeFrame: 6 months
measure: Status of Asthma exacerbations
timeFrame: 6 months
measure: Reduction of daily oral corticosteriod dose
timeFrame: 6 months
measure: Change of Pre-BD FEV1 (%pred)
timeFrame: 6 months
Secondary outcomes:
measure: Disease Prognosis
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: