2025-523020-50-00招募中2 期
A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER 01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
Aer Therapeutics Inc.4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- • Change from baseline in prebronchodilator FEV1 at Week 4
研究概览
简要总结
To evaluate the efficacy of AER-01 compared with placebo
研究设计
- 分配方式
- Randomized
- 主要目的
- Study Treatment
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •The study will enroll participants with a diagnosis of COPD. Each participant must meet all the following criteria to be enrolled in this study: • Is male or female ≥40 to ≤80 years of age.
- •Has a verified diagnosis of cigarette smoking-related COPD demonstrated by both of the following: o Is a current or former smoker with a history of ≥10 pack years of cigarette smoking. o Has a postbronchodilator FEV1/FVC ratio <0.
- •Has moderate to severe COPD defined in this study as a prebronchodilator FEV1 that is >25% and <60% of predicted normal at Visit
- •Participant meets the following spirometry performance criteria: o Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and
- •o Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during ≥1 of the prebronchodilator assessments at Visits 1 and
- •o Participant’s baseline (predose) FEV1 at Visit 3 must be within the greater of 12% or 100 mL of the mean FEV1 obtained at the 2 Screening visits.
- •Participant has a whole lung emphysema percent <40% based on automated analysis of the CT lung scan
- •Participant is on stable maintenance inhaler medications for COPD with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
- •Participant has maintenance medications, including an inhaled bronchodilator (short- or long acting beta adrenergic agonist or short- or long acting muscarinic antagonist).
- •Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study: • Participant has an active uncontrolled medical condition that, in the opinion of the investigator or medical monitor, might obfuscate the study data. Examples of such medical conditions that, if uncontrolled at Visit 1, would be exclusionary include: hypertension, diabetes, renal failure, coronary artery disease, cardiac failure, gastro esophageal reflux disease, cancer, alcohol use disorder, illicit drug use, or psychiatric disease.
- •Participant has active lung infection with nontuberculous mycobacteria, Pseudomonas aeruginosa, or Staphylococcus aureus.
- •Participant has received any vaccine within 7 days prior to Day
- •Participant is using dupilumab or tezepelumab for control of COPD, or any medical condition. Note: Patients who are taking benralizumab, mepolizumab, or omalizumab at a stable dose for ≥6 months are not excluded.
- •Participant has a hypersensitivity to fexlamose or to any of the excipients or placebo components.
- •Participant has active or latent pulmonary tuberculosis.
- •Participant has moderate or severe abnormalities in liver or renal function tests at Screening (ie, Grade >2 abnormalities).
- •Participant has primary diagnosis of non-CF bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
- •Participant has a finding on their screening CT lung scan of varicose or cystic bronchiectasis affecting >1 lobe or of cylindrical bronchiectasis affecting >2 lobes.
- •Participant has a finding on their screening CT lung scan of "tree in bud" opacities (indicative of small airway inflammation/infection).
- •Participant has a lung nodule discovered on their screening CT lung scan that, in the opinion of the site investigator, requires a timely work-up that would be adversely affected by participation in the study. In making this assessment, the site investigator should consider the size and appearance of the nodule and the guidance provided by the Fleischner Society.
- •Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 3).
- •Participant has had a viral respiratory tract infection (including coronavirus) in the 4 weeks prior to Screening.
- •Participant is currently using any vaping product or has used a vaping product within 1 week of signing the informed consent.
- •Participant is currently smoking cannabis or has smoked cannabis within 1 week of signing the informed consent.
结局指标
主要结局
• Change from baseline in prebronchodilator FEV1 at Week 4
• Change from baseline in prebronchodilator FEV1 at Week 4
次要结局
- 1. Change from baseline in CT MPSS at w 4
- 2. Percentage of participants who have treatment related reduction of MPSS
- 3. Change from baseline in SGRQ-C at w 4
- 4. Percentage of participants with ≥4 unit decrease from baseline in SGRQ-C at w 4
- 5. Change from baseline in prebronchodilator FVC at w 4
- 6. Change from baseline in SpO2 at w 4
- 7. Incidence of AEs throughout the study
- 8. Hematology, biochemistry, and urinalysis parameters assessed throughout the study
- 9. Incidence of GGO as detected by CT lung scan at w 4
研究者
Jordan Low
Scientific
Aer Therapeutics Inc.
研究点 (4)
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