NCT01088633已完成不适用
Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease
Fraunhofer-Institute of Toxicology and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Characterization of particles in exhaled breath of subjects with COPD compared with healthy smokers.
研究概览
简要总结
This study is aiming at evaluating the characteristics of particle emission in subjects with different stages of chronic obstructive pulmonary disease (COPD) compared with healthy smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, aged ≥ 18 years
- •COPD: Physician diagnosis of chronic obstructive pulmonary disease (COPD GOLD I to IV according to GOLD guidelines)9
- •Healthy smokers: current smokers with a history of at least 10 packyears and no signs of bronchial obstruction in spirometry (FEV1 >= 80% pred, FEV1/FVC >= 70%)
- •Able and willing to give written informed consent
- •Women will be considered for inclusion if they are:
- •not pregnant, as confirmed by pregnancy test, and not nursing
- •of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)
- •of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence) - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study , implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
- •Available to complete all study measurements
排除标准
- •History of lower respiratory tract infection four weeks prior to the informed consent visit
- •Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to tuberculosis, bronchiectasis or cystic fibrosis)
- •History of drug or alcohol abuse
- •Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
- •Inability to abstain from bronchodilators according to section 8.2 (Prohibited medication)
- •Risk of non-compliance with study procedures
结局指标
主要结局
Characterization of particles in exhaled breath of subjects with COPD compared with healthy smokers.
时间窗: within one day
At visit 2, the exhaled particle analysis will be performed. These measurements will be repeated after 2 hours on the same day. Visit 3: After a baseline exhaled particle analysis, the subjects will inhale nebulized saline (2.5 ml of a 0.9 % NaCl-solution). Aerosol generation and transport will be recorded immediately after the end of inhalation as well as 2 hours and 4 hours.
次要结局
未报告次要终点
研究者
Prof. Dr. Jens Hohlfeld, MD
Division director
Fraunhofer-Institute of Toxicology and Experimental Medicine
研究点 (2)
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