Eosinophilic Asthma Clinical Trial
Official title:
A Single-blind (Patient-blind), Randomized, Placebo-controlled, Intranasal Administration Study on Mechanisms and Potential Efficacy of AD17002 in Subjects With Poorly Controlled, Moderate to Severe Eosinophilic Asthma
This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it aims to answer are 1. Could the LTh(αK) intranasal treatment improve the clinical condition of these patients? 2. Could patients self-administrate LTh(αK) via the intranasal route? 3. Is the LTh(αK) at multiple doses safe for asthmatic patients? 4. Participants will be asked to self-administrate two doses per week for a total of 6 weeks (11 doses). A diary on LTh(αK) usage, adverse events, and reliever medication will be recorded.
Eosinophilic asthma is recognized as a sub-phenotype of asthma based on the pattern of inflammatory cellular infiltration in the airway. Eosinophilic asthma can be associated with increased asthma severity, atopy, late-onset disease, and steroid refractoriness. Induced sputum cell count is the standard for identifying eosinophilic inflammation in asthma and fractional exhaled nitric oxide (FeNO) and serum periostin are emerging as potential surrogates. The Type I and III interferons (IFNs) can negatively regulate the allergic reaction, and their production from mucosal epithelium is reported to be lower in patients with asthma. The investigational intranasal pharmaceutical product named AD17002 contains a detoxified Escherichia coli heat-labile enterotoxin, LTh(αK). Studies have shown that AD17002 enhanced the production of Type I and III IFNs from mucosal epithelial cells. Studies also supported that AD17002 attenuates allergic reactions. The safety and tolerability of LTh(αK) have been demonstrated in several clinical trials as an intranasal adjuvant for influenza vaccine (NCT03293732 and NCT03784885) or an intranasal immunomodulator for respiratory hypersensitivity (NCT04088721) and viral infection (NCT05069610 and NCT05541510). This study is conducted to determine the potential efficacy and mechanism of LTh(αK) 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-administrated 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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