This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it seeks to answer are 1. Could the AD17002 intranasal immunomodulator improve the clinical condition of eosinophilic asthmatic patients? 2. Could patients self-administer AD17002 via the intranasal route? 3. Is the AD17002 at multiple doses safe for asthmatic patients? 4. Participants will be asked to self-administer two doses per week for a total of 6 weeks (11 doses). A diary on AD17002 usage, adverse events, and reliever medication will be recorded.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Taipei Medical University Hospital
Taipei, Taiwan, Taiwan
FEV1 improvement
Lung function tests with spirometry
Time frame: Day 1 to Day 78
Change to the use of Short-Acting Beta Agonists (SABA)
The number of use of rescue Short-Acting Beta Agonists
Time frame: Day 1 to Day 78
Fractional exhaled nitric oxide (FeNO) change
Change to the FeNO levels
Time frame: Day 1 to Day 78
changes of sputum eosinophil counts
Change to the induced sputum eosinophils' count
Time frame: 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.
Time frame: Day 1 to Day 78
Corticosteroid used to control asthma
Numbers of corticosteroid used, inhaled or oral
Time frame: 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
Time frame: Day 1 to Day 78
Immunological biomarkers of serum
Change of concentration from baseline of induced serum IL-4, -5, -13
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Time frame: Day 1 to Day 78
Peripheral eosinophil count
Change of cell numbers from baseline of peripheral eosinophil count
Time frame: Day 1 to Day 78
Adverse events_clinical visit
Clinical visit and check up by physicians
Time frame: Day 1 to Day 36 and Day 78
Adverse events-Diary
Patient self report adverse events via diary
Time frame: Day 1 to Day 78