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NCT Number: NCT06456450

Taiwan Severe Asthma Biologic Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location status: Recruiting

Location contact

Pin-Kuei Fu, MD, PhD

CONTACT

[email protected]

886-4-23592525 ext. 3213

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological Treatment for severe asthma patients

Biological

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

Other names: Omalizumab, Mepolizumab, Benralizumab, Dupilzumab, Tezepelumab

Primary outcomes

  1. Status of Asthma Control

    Time frame: 6 months

    Mean change in Asthma Control Test score after biologic initiation.

  2. Status of Asthma exacerbations

    Time frame: 6 months

    Annual frequency of exacerbations after biologic initiation.

  3. Reduction of daily oral corticosteriod dose

    Time frame: 6 months

    Percentage of daily oral corticosteroids dose reduction after biologic initiation.

  4. Change of Pre-BD FEV1 (%pred)

    Time frame: 6 months

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

Secondary outcomes

  1. Disease Prognosis

    Time frame: 6 months

    • 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.
  2. Mortality

    Time frame: 6 months

    Define the mortality rate of the study cohort

Study contacts

Contact information is provided by the study sponsor or research team.

Pin-Kuei Fu, MD.,PhD.

CONTACT

[email protected]

886-4-23592525 ext. 6535

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Collaborators

  • Chang Gung Memorial Hospital
  • E-DA Hospital
  • National Cheng-Kung University Hospital
  • National Yang Ming Chiao Tung University Hospital

Registry information

Acronym: TARGET

Important dates

Study start
2023
Primary completion
2043
Study completion
2043
First posted
Jun 13, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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