DRKS00000754已完成1 期
A Randomized, Open Label, Cross-over Scintigraphic Evaluation of Lung Deposition of Alpha1-Proteinase Inhibitor (Human) (A1-PI(H) Inhalation Solution) using Two Inhalation Modes of the I-neb® Nebulizer in Healthy Subjects and Subjects with Cystic Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria of healthy subjects:
- •Forced expiratory volume measured in 1 second (FEV1) 90% predicted as defined by age, gender, and height [1].
- •Inclusion criteria of subjects with CF:
- •Confirmed diagnosis of CF - one or more clinical findings consistent with CF and at least 1 of the following:
- •a) Sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis test
- •b) A genotype with 2 identifiable mutations consistent with CF (?F508 homozygous OR 2 alleles known to cause a class I, II, or III mutation)
- •FEV1 30% predicted as defined by age, gender, and height
排除标准
- •Current smoker or a smoking history of > 10 pack-years (e.g. 20 cigarettes/day for 10 years). A subject who has used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars or pipe tobacco) will be excluded.
- •Any signs of chronic or acute hepatitis A, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection (negative serology test for HIV and viral hepatitis). In case of positive serology test for viral hepatitis, vaccination status or negative IgM should be available.
- •Has an oxygen saturation (as measured by pulse oximetry) < 85% on room air
- •Change of routine CF treatment 2-4 weeks before screening
- •IgA deficiency subjects
研究者
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