EUCTR2007-007940-92-HU进行中（未招募）不适用
A PLACEBO CONTROLLED, RANDOMIZED, PARALLEL COHORT, SAFETY AND TOLERABILITY STUDY OF TWO DOSE LEVELS OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN PATIENTS WITH BRONCHIECTASIS COMPLICATED BY CHRONIC INFECTION DUE TO PSEUDOMONAS AERUGINOSA
试验速览
- 阶段
- 不适用
- 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
- 性别
- All
入选标准
- •1) Written informed consent obtained from the patient or legal representative prior to the performance of any study related procedures
- •2) Male or female study subjects= 18 years of age
- •3) Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT of the chest
- •4) History of chronic infection with P. aeruginosa, defined as:
- •At least 1 documented positive culture in the 12 months prior to screening
- •AND One or more documented courses of antibiotics for respiratory tract infection in the past 12 months, including either: One course of IV antibiotics OR
- •One treatment failure with oral antibiotics requiring additional antibiotic treatment for respiratory tract infection
- •5) Confirmation of infection with P. aeruginosa at screening (defined as mucopurulent sputum positive for P. aeruginosa)
- •6) SaO2 = 90% at Screening while breathing room air
- •7) Ability to comply with study medication use, study visits, and study procedures as judged by the investigator
- •8) Ability to produce at least 0.5 grams sputum or be willing to undergo an induction to produce sputum for clinical evaluation
- •9) Female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at Screening
- •2) Subjects with hemoptysis of = 60 ml within 4 weeks prior to screening
- •3) Positive pregnancy test or lactation. All women of child bearing potential will be tested
- •4) Bronchiectasis due to cystic fibrosis (CF), bronchopulmonary Aspergillus, aspiration of foreign body, or secondary to lung compression from tumors
- •5) History of non-tuberculous mycobacterial and/or Aspergillus infection requiring treatment or treated within 2 years prior to screening
- •6) History ofAllergic Bronchopulmonary Aspergillosis requiring systemic steroid treatment or treated within 3 months prior to screening
- •7) Pulmonary tuberculosis requiring treatment or treated within two years prior to screening
- •8) History of Lung transplantation
- •9) More than 3 bronchiectasis exacerbations within 12 months prior to screening
- •10) Treatment for bronchiectasis exacerbation within the 4 weeks prior to screening.
- •11) Radiographic finding of new pulmonary infiltrate(s) within 2 months prior to screening
- •12) Presence of any clinically significant cardiac disease as determined by Investigator: The QTc criteria for Exclusion of subjects is: males QTc> 450 msec (or 0.450 seconds), females QTc> 470 msec (or 0.470 seconds)
- •13) Use of any inhalation or systemic antibiotics (IV antibiotics, or oral antibiotics) within 4 weeks prior to Study Day 1
- •14) Initiation of chronic therapy (e.g., TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics, chronic suppressive antibacterial treatment) within the 28 days prior to Study Day 1
- •15) Administration of any investigational drug within 8 weeks prior to screening
- •16) Hypersensitivity to aminoglycosides
- •17) Evidence of biliary cirrhosis with portal hypertension
- •18) AST or ALT = X 3 times the upper limit of normal at Screening
- •19) Absolute Neutrophil Count = 1000 performed at Screening
- •20) Serum creatinine > X1.8 times normal performed at Screening
- •21) History of daily, continuous oxygen supplementation
- •22) Smoking tobacco or any substance within 6 months prior to screening, and throughout the study
- •23) History of alcohol, medication, or illicit drug abuse within the 1 year prior to screening
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