A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover, Multicenter Clinical Study to Assess the Efficacy and Safety of Once Daily Administration of Lupin Tiotropium Bromide Inhalation Powder Compared to SPIRIVA® HANDIHALER® and Placebo in Patients With COPD Including a 12-Week Open Label Extension to Assess Inhaler Robustness
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Lupin, Inc.
- 入组人数
- 377
- 试验地点
- 34
- 主要终点
- Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose
研究概览
简要总结
The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- •Male and non-pregnant female subjects (40 years of age and older).
- •Patients with diagnosis of COPD according to the GOLD guidelines.
- •Post-bronchodilator FEV1 <80% of the predicted value at the screening visit.
- •Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.
- •Current or former smokers (e.g., with history of = 10 pack-years).
- •Written informed consent.
排除标准
- •Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
- •History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
- •Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.
- •Treatment for COPD exacerbation within 12 weeks prior to the screening visit.
- •Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit.
- •Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.
研究组 & 干预措施
Test Product (tiotropium bromide inhalation powder)
Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).
干预措施: Test Product (tiotropium bromide inhalation powder) (Drug)
Reference Product (Spiriva®)
Single dose of reference product (Spiriva®) 18 mcg
干预措施: Reference Product (Spiriva®) (Drug)
Placebo
Single dose of placebo inhalation powder
干预措施: Placebo (Drug)
结局指标
主要结局
Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose
时间窗: 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
To show clinical bioequivalence in the efficacy of the test product as a single dose versus reference product based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.
Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo
时间窗: 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
This measure is to demonstrate that test product as a single dose and reference product are superior to placebo based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.
次要结局
未报告次要终点