NCT02109406已完成2 期
A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
研究概览
简要总结
This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.
- •Current or former smokers with a history of ≥10 pack years of cigarette smoking.
- •Post-bronchodilator FEV1/FVC ratio of <70%.
- •Pre-bronchodilator FEV1 must be <80% predicted
- •Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.
排除标准
- •Pregnancy: Women who are pregnant or lactating.
- •Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- •Primary diagnosis of asthma.
- •Alpha-1 antitrypsin deficiency as the cause of COPD
- •Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.
- •Poorly controlled COPD (hospitalization due to poorly controlled COPD within 3 months of Screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening or during Screening.
- •Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of Randomization.
- •Clinically significant abnormal ECG.
研究组 & 干预措施
AZD2115 Dose 1
Experimental
AZD 2115, Dose 1 administered as two inhalations BID
干预措施: AZD2115 Dose 1 (Drug)
AZD 2115 Dose 2
Experimental
AZD 2115, Dose 2 administered as two inhalations BID
干预措施: AZD 2115, Dose 2 (Drug)
Placebo MDI
Placebo Comparator
Placebo MDI administered as two inhalations BID
干预措施: Placebo MDI (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
时间窗: 14 Days
次要结局
- Change from baseline in morning pre dose trough FEV1(14 Days)
- Time to onset of action(Day 1)
- Peak change in FEV1(Day 1)
- Forced vital capacity (FVC) AUC0-12 relative to baseline(14 Days)
- Change from baseline in 12-hour post dose trough FEV1(14 Days)
研究者
研究点 (1)
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