Taiwan Severe Asthma Biologic Registry

NCT06456450 | Recruiting DMC

• 1 other identifier: CE24049B
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.Determine risk factors associated with poor asthma control.
2. 2.Support the development of effectiveness and safety of therapeutic principles
3. 3.To discover the real-world effectiveness of different biologics ( Clinical remission)
4. 4.To discover the impact of initiating biologics for severe asthma patients.
5. 5.To evaluate the prevalence of biologics switching and its benefits for patients.
6. 6.To compare the achievement rate of clinical remission among different biologics.

Conditions

Pulmonary Disease; Asthma

Keywords

Severe Asthma; Registry; Biologic

Outcome Measures

Primary Outcomes (4)

• Status of Asthma Control

  Mean change in Asthma Control Test score after biologic initiation.

  6 months

• Status of Asthma exacerbations

  Annual frequency of exacerbations after biologic initiation.

  6 months

• Reduction of daily oral corticosteriod dose

  Percentage of daily oral corticosteroids dose reduction after biologic initiation.

  6 months

• Change of Pre-BD FEV1 (%pred)

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

  6 months

Secondary Outcomes (2)

• Disease Prognosis

  6 months

• Mortality

  6 months

Study Arms (5)

Omalizumab

Severe asthma patients who are treated with omalizumab after January 1, 2020.

Biological: Biological Treatment for severe asthma patients

Mepolizumab

Severe asthma patients who are treated with mepolizumab after January 1, 2020.

Biological: Biological Treatment for severe asthma patients

Benralizumab

Severe asthma patients who are treated with benralizumab after January 1, 2020.

Biological: Biological Treatment for severe asthma patients

Dupilzumab

Severe asthma patients who are treated with dupilzumab after January 1, 2020.

Biological: Biological Treatment for severe asthma patients

Tezepelumab

Severe asthma patients who are treated with Tezepelumab after January 1, 2020.

Biological: Biological Treatment for severe asthma patients

Interventions

Biological Treatment for severe asthma patients BIOLOGICAL

Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance

Also known as: Omalizumab, Mepolizumab, Benralizumab, Dupilzumab, Tezepelumab

Benralizumab; Dupilzumab; Mepolizumab; Omalizumab; Tezepelumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Asthma Patient

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• E-DA Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• National Yang Ming Chiao Tung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Asthma

Interventions

Omalizumab; mepolizumab; benralizumab; tezepelumab

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Pin-Kuei Fu, MD.,PhD.

CONTACT

886-4-23592525; yetquen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trail Center

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 13, 2024
• Study Start: November 11, 2023
• Primary Completion (Estimated): February 28, 2043
• Study Completion (Estimated): February 28, 2043
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

TW (1)