NCT00129831已完成2 期
Dose Escalation Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Safety variables (laboratory tests, ECG, adverse events)
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female patients with mild to moderate stable COPD, diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 40-75 years of age
- •Prebronchodilator baseline forced expiratory volume in 1 second (FEV1) 30-80% of the Quanjer predicted normal value (Quanjer et al. 1993) and at least 0.75 L with FEV1/forced vital capacity (FVC) < 70% of predicted [GOLD guidelines].
- •Previous smokers (>10 pack-years). Ten pack years are defined as: 20 cigarettes a day for 10 years; 10 cigarettes a day for 20 years; or 40 cigarettes a day for 5 years. Current smokers, with >10 pack year history, can be included under certain conditions.
- •Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges:
- •oral body temperature between 35.0-37.5 °C;
- •systolic blood pressure, 100-170 mm Hg;
- •diastolic blood pressure, 50-100 mm Hg;
- •pulse rate, 50 - 90 beats per minute (bpm).
- •Patients must weigh a minimum of 50 kg to participate in this study.
- •Able to provide written informed consent prior to study participation.
- •Able to communicate well with the investigator and comply with the requirements of the study.
排除标准
- •Pregnant women or nursing mothers.
- •Patients with a QTc interval above 0.43 seconds for males and 0.45 seconds for females at the screening visit. If pre-treatment values on Day 1 of the treatment periods exceed 0.45 and 0.47 seconds for males and females respectively the visit may be re-scheduled once.
- •Patients with a history of prolonged QTc intervals, or a family history of prolonged QT syndrome.
- •Predominant diagnosis of asthma. (Patients must present without evidence of active asthma.)
- •Patients who have been hospitalized or had emergency treatment for acute COPD exacerbation in the one month prior to or during screening.
- •Patients who have had a respiratory tract infection within one month prior to screening.
- •Patients with concomitant pulmonary disease, including a history of cancer
- •Other exclusion criteria apply.
结局指标
主要结局
Safety variables (laboratory tests, ECG, adverse events)
次要结局
- Lung function tests
- Pharmacokinetics
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
An A/B Dose Escalation Study of AbGn-7 Alone and With FOLFOX7 Treatment in Patients With Advanced Solid TumorsSolid Tumor of Epithelial OriginGastric CancerNCT01466569AbGenomics B.V Taiwan Branch13
已完成
1 期
Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male VolunteersHealthyNCT02209714Boehringer Ingelheim24
已完成
1 期
A Safety Study of LY3372689 Given By Mouth to Healthy ParticipantsHealthyNCT03819270Eli Lilly and Company23
已完成
1 期
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257Healthy SubjectsNCT00722501Wyeth is now a wholly owned subsidiary of Pfizer48
已完成
1 期
Study Evaluating The SBI-087 In Subjects With Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT00714116Pfizer30