AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma (NCT05985694) | Clinical Trial Compass
CompletedPhase 1/2
AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma
Taiwan40 participantsStarted 2023-11-27
Plain-language summary
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.
Who can participate
Age range20 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Subject 20-80 years of age on the day of signing informed consent
ā. Subject who is not a current smoker with poorly controlled, moderate to severe eosinophilic asthma based on GINA 2022 criteria.
ā. The subject is diagnosed with asthma.
ā. Subjects who have the post-bronchodilator reversibility of Forced expiratory volume 1 (FEV1) of ā„ 12% and ā„ 200 mL in response to a SABA at the screening visit or documented in the medical chart within 3 months of the screening visit.
ā. Subjects who have ā„3% eosinophil counts in the induced sputum within 7 days of Visit 1.
ā. Subjects with ACT scores ā¤ 19 under regular low to moderate-dose inhaled corticosteroids (ICS) and/or a combination with inhaled long-acting beta 2 agonists for at least 3 months before the Screening Visit.
ā. Have a negative serum pregnancy test at the screening, and randomization visits (female subjects of childbearing potential). A female subject who is of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the trial. Acceptable birth control methods are intrauterine devices, hormonal contraception, diaphragm with spermicide, contraceptive sponge, condoms, and vasectomy, as per local regulations or guidelines.
. A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as one who has either
Exclusion criteria
ā. Subjects with serious underlying chronic illness or severe systemic disease, including SLE, malignant diseases, uremia and heart failure, or abnormal liver function.
ā. Subjects without a recent respiratory tract infection within 3 weeks before the study.
ā. Subjects without a recent COVID-19 infection within 1 month before study.
ā. Subjects with clinically important lung disease, including but not limited to COPD (Chronic Obstructive Pulmonary Disease), chronic respiratory infection, lung cancer, etc.
ā. Arrhythmia, myocardial infarction, or stroke in the last 3 months.
ā. Active COVID-19 disease (SARS-CoV-2 Lateral flow tests (LFA)-positive) at Screening.
ā. A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized.
ā. A clinical history of active chronic sinusitis (\> 3 months).