EUCTR2011-000442-38-PL进行中（未招募）1 期
Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection 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
- 300
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 or assent obtained from the patient, parent or legal guardian prior to the performance of any study related procedures
- •2) Male or female study subjects = 6 years of age (or older, if restricted by the local IRB/EC) at Screening
- •3) Diagnosis of CF confirmed by a positive sweat test > 60 mEq/L or > 60 mmol/L or by DNA analysis revealing both mutated alleles consistent with CF disease
- •4) History of chronic infection with Pa confirmed by three documented positive cultures for Pa within the 2 years prior to Screening with at least one obtained within 6 months prior to Screening. The cultures could be obtained from the following respiratory secretions: sputum, deep throat swabs, or broncho-alveolar lavage fluid specimens
- •5) History of documented pulmonary exacerbation requiring treatment with antibiotics in the 12 months prior to Screening
- •6) Sputum culture positive for Pa at Screening
- •7) Forced expiratory volume in 1 second (FEV1) = 25% of predicted value at Screening using spirometer provided by sponsor
- •8) Oxygen saturation (SaO2) = 90% while breathing room air at Screening
- •9) Ability to comply with study drug use, study visits, and study procedures as judged by the Investigator
- •10) Ability to expectorate = 0.4 mL of sputum
- •11) Willingness to have specimens stored for microbiology and pharmacokinetic testing (no genetic testing)
- •12) Women of childbearing potential must have a negative result on their serum pregnancy test at Screening and use reliable methods of contraception (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) throughout the study duration. Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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) <25% of predicted value at Screening using spirometer provided by Insmed
- •2) History of hypersensitivity to aminoglycosides
- •3) Prior exposure to Arikace™ (including clinical study)
- •4) History of major complications of lung disease (including atelectasis, pneumothorax, major pleural effusion) within 8 weeks prior to Screening
- •5) Hemoptysis of =60 mL in a 24-hour period within 4 weeks prior to Screening
- •6) History of acute pulmonary exacerbation requiring antibiotic treatment within 4 weeks prior to Screening
- •7) History of upper respiratory tract infection within 2 weeks prior to Screening
- •8) Use of antipseudomonal antibiotics (IV antibiotics, inhalation antibiotics, or oral) within 4 weeks prior to Day 1
- •9) Radiologic finding of new pulmonary infiltrate(s) within 3 months prior to Screening, or presence of other abnormalities suggesting clinically significant active pulmonary disease other than CF
- •10) Initiation of chronic therapy (e.g., TOBI®, Colomycin®, other inhaled antibiotics, high-dose ibuprofen, bronchodilators, inhaled anti-inflammatory agents including steroids, low dose maintenance steroids, rhDNase, hypertonic saline, macrolides) within 4 weeks prior to study Day 1
- •11) History of pulmonary tuberculosis or non-tuberculous mycobacterial lung disease treated within 2 years prior to Screening or requiring treatment at the time of Screening
- •12) History of Allergic Broncho-Pulmonary Aspergillosis requiring systemic steroid treatment or any other condition requiring systemic steroids at a dose = equivalent of 10 mg/day of prednisone within 3 months prior to Screening
- •13) Presence of any clinically significant cardiac disease as determined by investigator and/or, if QTc data are available, QTc prolongation > 450 msec (0.450 seconds) for males or > 470 msec (0.470 seconds) for females or >440 msec (0.440 seconds) for all subjects 6 to 12 years of age
- •14) Acquired and primary immunodeficiency syndromes
- •15) History of hepatitis C or chronic active hepatitis B infection
- •16) Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within one year prior to Screening or anticipated during the study period
- •17) History of biliary cirrhosis with portal hypertension
- •18) History of lung transplantation
- •19) Elevated AST, ALT or GGT = 3× the upper limit of normal (ULN) at Screening
- •20) Absolute neutrophils count = 1000 at Screening
- •21) Serum creatinine > 2× ULN at Screening
- •22) Daily, continuous oxygen supplementation
- •23) Supplemental oxygen requirement of greater than 2 L/min at night
- •24) Administration of any investigational products within 8 weeks prior to study Day 1
- •25) Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- •26) History of alcohol, medication, or illicit drug abuse within the 1 year prior to Screening
- •27) Smoking tobacco or any substance within 6 months prior to Screening or anticipated inability to refrain from smoking throughout the study
- •28) Positive pregnancy test or lactation at Screening. All women of child bearing potential will be tested for pregnancy. Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile
- •29) Any condition which in the opinion of the investigator interferes with ability to safely complete the study or ad
研究者
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