NCT06643078已完成3 期
A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 2
- 主要终点
- Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
研究概览
简要总结
To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
single blind（Outcomes Assessor）
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of Chinese ethnicity, at least 40 years of age.
- •Patients with with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to according to GOLD criteria
- •Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at visit
- •Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.
排除标准
- •Patients with any of the following diseases:α-1 antitrypsin deficiency, asthma, active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, obliterated bronchiolitis, sarcoidosis, or other diseases that the investigator considers to be at risk of safety/efficacy for the patient, e.g lung fibrosis, pulmonary hypertension, interstitial lung disorder, active bronchiectasis.
- •Patients with a history of serious cardiovascular disease;
- •Patients with Type I or uncontrolled Type II diabetes;
- •Patients with paradoxical bronchospasm, narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (benign prostatic hyperplasia patients who were stable on treatment could have been considered), bladder-neck obstruction, severe renal impairment, or urinary retention, or any other medical history, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic agent;
- •Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior to screening (Visit 1) or screening.
- •Patients who have had an acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, pharyngitis or urinary tract infections within 4 weeks prior to screening (Visit 1) or screening.
- •Patients who have had a COPD exacerbation that required treatment with systemic steroids, hospitalization or emergency treatment in the 8 weeks prior to screening (Visit 1).
- •Patients with conditions contraindicated for treatment with or having a history of allergy or hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: Anticholinergic/muscarinic receptor antagonist, Long- or short-acting β2-agonists, Sympathomimetic amines, Lactose/milk proteins, or any of the other excipients of the delivery system.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
HL231 Solution for Inhalation
Experimental
干预措施: HL231 Solution for Inhalation (Drug)
Ultibro
Active Comparator
干预措施: Ultibro 110μg/50 μg (Drug)
结局指标
主要结局
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
时间窗: 26 weeks
次要结局
- Rate of Moderate to Severe COPD Exacerbations within weeks 26 and 52(26, 52 weeks)
- Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) at week 6,12,18,34,42,52.(6,12,18,34,42,52 weeks)
- Standardized FEV1 Area Under the Curve (AUC) From zero to 4 Hours at Day 1 and Week 26(Day 1,week 26)
- Change from baseline in COPD assessment test (CAT) score at Week 26 and 52.(26, 52 weeks)
- Rescue Medication Use: Summary of the Mean Daily Number of Puffs of Rescue Medication within Week 26 and 52.(26, 52 weeks)
- Adverse event rate(52 weeks)
研究者
研究点 (2)
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