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| Name | Class |
|---|---|
| Taipei Medical University Hospital | OTHER |
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This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it seeks to answer are
This study was conducted to determine the potential efficacy and mechanism of AD17002 as an immunomodulator in attenuating the severity of clinical manifestations in patients with unstable, moderate-to-severe eosinophilic asthma. Patients with clinical history and ongoing eosinophilic asthma will be randomly assigned to either AD17002 (10 μg or 20 μg) or placebo, per 3-4 days, in a 1:1 ratio, in a single-blinded (patient-blinded) fashion. The nasal administration will be self-administered by participants. Progression and improvement in asthmatic symptoms will be recorded. All study subjects will sign ethics committee-approved informed consent forms before participating in any trial-related activities. Subjects who participate in this trial of AD17002 will provide information about the dosing, efficacy, and safety of the new indication that will guide its future clinical use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Placebo | Placebo Comparator | Formulation buffer |
|
| Cohort 1 Low dose | Experimental | Formulation buffer + 10 μg AD17002 |
|
| Cohort 2 Placebo | Placebo Comparator | Formulation buffer |
|
| Cohort 2 High dose | Experimental | Formulation buffer + 20 μg AD17002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD17002 | Drug | The dosing days of AD17002 are: Days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 improvement | Lung function tests with spirometry | Day 1 to Day 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Change to the use of Short-Acting Beta Agonists (SABA) | The number of use of rescue Short-Acting Beta Agonists | Day 1 to Day 78 |
| Fractional exhaled nitric oxide (FeNO) change | Change to the FeNO levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yushen Hsu, Ph.D. | Advagene Biopharma | Study Chair |
| Han-Pin Kuo, MD. Ph.D. | Taipei Medical University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan | Taiwan |
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| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
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| ID | Term |
|---|---|
| C027538 | heat-labile enterotoxin, E coli |
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| Placebo | Drug | Formulation buffer. Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32. |
|
|
| Day 1 to Day 78 |
| changes of sputum eosinophil counts | Change to the induced sputum eosinophils' count | Day 1 to Day 78 |
| Asthma Control Test (ACT) scores improvement | Change to the ACT scores. A maximum score of 25 points indicates complete asthma control. A score between 20 and 25 represents well controlled asthma, while a score of 19 or below represents not well controlled asthma, and a score less than 16 indicates very poorly controlled asthma. | Day 1 to Day 78 |
| Corticosteroid used to control asthma | Numbers of corticosteroid used, inhaled or oral | Day 1 to Day 78 |
| Immunological biomarkers of sputum | Changes in the concentration of sputum IL-4, -5, -13, IFN-α, eosinophil peroxidase (EPO), eosinophil cationic protein (ECP) from the baseline | Day 1 to Day 78 |
| Immunological biomarkers of serum | Change of concentration from baseline of induced serum IL-4, -5, -13 | Day 1 to Day 78 |
| Peripheral eosinophil count | Change of cell numbers from baseline of peripheral eosinophil count | Day 1 to Day 78 |
| Adverse events_clinical visit | Clinical visit and check up by physicians | Day 1 to Day 36 and Day 78 |
| Adverse events-Diary | Patient self report adverse events via diary | Day 1 to Day 78 |
| D007960 |
| Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |