Taiwan Severe Asthma Biologic Registry

Asthma Clinical Trial

— TARGET  

Official title:

Taiwan Severe Asthma Biologic Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456450
• Other study ID #: CE24049B
• Status: Recruiting
• Start date: November 11, 2023
• Est. completion date: February 28, 2043

Study information

• Verified date: June 2024
• Source: Taichung Veterans General Hospital
• Contact: Pin-Kuei Fu, MD.,PhD.
• Phone: 886-4-23592525
• Email: yetquen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2043
• Est. primary completion date: February 28, 2043
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Pulmonary Disease

Intervention

Biological:
• Biological Treatment for severe asthma patients
Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (5)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital	Chang Gung Memorial Hospital, E-DA Hospital, National Cheng-Kung University Hospital, National Yang Ming Chiao Tung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of Asthma Control	Mean change in Asthma Control Test score after biologic initiation.	6 months
Primary	Status of Asthma exacerbations	Annual frequency of exacerbations after biologic initiation.	6 months
Primary	Reduction of daily oral corticosteriod dose	Percentage of daily oral corticosteroids dose reduction after biologic initiation.	6 months
Primary	Change of Pre-BD FEV1 (%pred)	Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)	6 months
Secondary	Disease Prognosis	Describe the Cross-sectional phenotypic or pathophysiological (endotype) characteristics of poor asthma control.; Describe the natural history, intervention responsiveness and long-term prognosis of severe asthma.	6 months
Secondary	Mortality	Define the mortality rate of the study cohort	6 months