EUCTR2006-006980-22-SK进行中（未招募）1 期
MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
入选标准
- •CF study subjects with mild to moderate obstructive lung disease (FEV1% predicted = 40%) will be eligible for enrollment. Study subjects must be 6 years old or older. To be eligible, study subjects must also have history of sputum containing Pseudomonas aeruginosa.
- •1) Written informed consent prior to the performance of any study related
- •2) Male or female study subjects = 6 years of age or older
- •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
- •4) History of chronic infection with P. aeruginosa (defined as 3 documented positive
- •cultures in the prior 2 years of which at least one was obtained in the 3 months
- •prior to randomization. The cultures could be obtained from the following
- •respiratory secretions:
- •sputum, throat swabs, nasopharyngeal swabs or broncho-alveolar lavage fluid
- •5) Study subjects must produce a screening specimen (expectorated or induced
- •sputum, throat swabs, nasopharyngeal swabs or broncho-alveolar lavage fluid)
- •that is positive for growth of P. aeruginosa
- •6) FEV1 = 40% of predicted at Screening
- •7) SaO2 = 90% at Screening while breathing room air
- •8) Ability to comply with study medication use, study visits, and study procedures as
- •judged by the investigator
- •9) Ability to produce 0.5 grams sputum or be willing to undergo an induction to
- •produce sputum for clinical evaluation
- •10)Clinically stable with no evidence of acute upper or lower respiratory tract
- •infection or history of pulmonary exacerbation within the 4 weeks prior to
- •randomization
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Administration of any investigational drug within 8 weeks prior to Screening
- •2) Emergency room visit or hospitalization for CF or respiratory-related illness within
- •the 4 weeks prior to screening
- •3) History of alcohol, medication, or illicit drug abuse within the 1 year prior to
- •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 (IV antibiotics, all inhalation antibiotics,
- •oral fluoroquinolones) within the 28 days prior to screening.
- •8) Initiation of chronic therapy (i.e. TOBI®, high-dose ibuprofen, rhDNase, macrolide
- •antibiotics) within the 28 days prior to screening
- •9) History of sputum or throat swab culture yielding Burkholderia cepacia within 2
- •years of Screening
- •10)History of mycobacterial infection
- •11)History of biliary cirrhosis, portal hypertension, or splenomegaly (refer to study
- •12)GGT, AST, or ALT = 3 times the upper limit of normal at Screening visit
- •13)ANC = 1000 performed at Screening visit
- •14)Serum creatinine > 1.5 times normal performed at Screening visit
- •15)History of daily, continuous oxygen supplementation or requirement for more
- •than 2 L/min at night
- •16)Change in chest x-ray at screening (or within the 3 months prior to screening)
- •with new onset infiltrates or that which compromise the safety of the study
- •patient or the quality of the study data
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