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

Transave, Inc.0 个研究点目标入组 60 人开始时间: 2007年8月22日最近更新: 2017年10月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Transave, Inc.
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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

•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. To be eligible, study subjects must also have history of sputum containing Pseudomonas aeruginosa.
•1) Written informed consent obtained from the patient or designated legal guardian prior to the performance of any study related procedures
•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
•Main criteria for inclusion of patients participating in the 18 months extension period:
•1) Written informed consent obtained from the patient or designated legal guardian prior to the performance of any study related procedures in the extension period
•2) Patient meets all of the above listed inclusion criteria (1-10) of the main protocol
•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 or Aspergillus infection
•11)History of biliary cirrhosis with portal hypertension, or splenomegaly (refer to study manual)
•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
•Main criteria for exclusion of patients participating in the 18 months extension period:
•1) Patient meets any criteria for exclusion as listed above in the main protocol
•2) Patient which met any criteria for study drug discontinuation in the main protocol (see section 5.3 Criteria for Study Drug Discontinuation)

研究者

发起方

Transave, Inc.

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