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| Name | Class |
|---|---|
| E-DA Hospital | OTHER |
| National Cheng-Kung University Hospital | OTHER |
| National Yang Ming Chiao Tung University Hospital | OTHER |
| Chang Gung Memorial Hospital |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Severe asthma patients who are treated with omalizumab after January 1, 2020. |
| |
| Mepolizumab | Severe asthma patients who are treated with mepolizumab after January 1, 2020. |
| |
| Benralizumab | Severe asthma patients who are treated with benralizumab after January 1, 2020. |
| |
| Dupilzumab | Severe asthma patients who are treated with dupilzumab after January 1, 2020. |
| |
| Tezepelumab | Severe asthma patients who are treated with Tezepelumab after January 1, 2020. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological Treatment for severe asthma patients | Biological | Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Prognosis |
| 6 months |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Severe Asthma Patient
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pin-Kuei Fu, MD.,PhD. | Contact | 886-4-23592525 | 6535 | yetquen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| C434107 | mepolizumab |
| C571386 | benralizumab |
| C000622721 | tezepelumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| OTHER |
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|
Define the mortality rate of the study cohort |
| 6 months |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |