EUCTR2005-004389-17-HU进行中（未招募）1 期
SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Written informed consent prior to the performance of any study related procedures
- •2) Male or female study subjects =13 years of age or older and weigth > 40 kilograms
- •3) Confirmed diagnosis of CF defined as a positive sweat chloride = 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features of the CF phenotype
- •4) Chronic infections with P. aeruginosa (defined as = 1 yr of positive cultures)
- •5) Study subjects must produce a screening sputum (expectorated or induced) that is positive for growth of P.
- •6) FEV1 = 40% of predicted at Screening
- •7) SaO2 = 90% at Screening while breathing room air
- •8) Ability to comply with medication use, study visits, and study procedures as judged by the investigator
- •9) Ability to produce sputum or be willing to undergo and induction to produce sputum for clinical evaluation (subjects will be asked to be consistent with expectorated or induction for the duration of the study)
- •10) Clinically stable with no evidance of acute upper or lower respiratory tract infections or current pulmonary
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Administration of any investigational drug within 4 weeks of Screening
- •2) Emergency room visit or hospitalization for CF or respiratory-related illness within 4 weeks prior to screening
- •3) History of alcohol, medication, or illicit drug abuse within 1 year of Screening
- •4) History of lung transplantation
- •5) Female of childbearing potential who is lactating or is not practicing an acceptable method of birth control (e.g.,abstinence, hormonal or barrier methods, partner sterilization, or IUD)
- •6) Positive pregnancy test. All women of child bearing potential will be tested
- •7) Use of any anti-pseudomonal antibiotics within 14 days of study treatment
- •8) Initiation of chronic therapy (ie. TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics) within 60 days of Screening
- •9) History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years of Screening or growth of
- •B. cepacia from the sputum or throat swab culture obtained at Screening
- •10) History of mycobacterial infection at Screening
- •11) History of biliary cirrhosis, portal hypertension, or splenomegaly (refer to study manual) or splenomegaly on
- •physical exam at Screening
- •12) GGTP, AST, or ALT = 2 times the upper limit of normal performed at the local or central laboratories on two
- •occasions at Screening
- •13) ANC= 1000 performed at the local or central laboratories on two occasions at Screening
- •14) Serum creatinine > 1.5 times normal performed at the local or central laboratories on two occasions at Screening
- •15) Changes in their physiotherapy technique or schedule during the week prior to Screening
- •16) History of daily, continuous oxygen supplementation or requirement for more than 2 L/min at night
- •17) Change in chest x-ray at Screening (or within the previous 3 months of Screening) with new onset infiltrates or that would compromise the safety of the study patient or the quality of the study data
研究者
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