Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)

Gilead Sciences, Inc.0 个研究点目标入组 105 人开始时间: 2011年10月13日最近更新: 2017年8月21日

试验速览

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•Aged 3 months to less than 18 years.
•Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria: sweat chloride level = 60 mEq/L by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more
•clinical features consistent with CF.
•Documented new onset of positive lower respiratory tract culture for PA within 30 days of study entry (screening visit) defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
•FEV1 = 80% predicted (for subjects = 6 years of age).
•Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 105
•F.1.2 Adults (18-64 years) no
•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

•Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit).
•Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit).
•History of hypersensitivity/adverse reaction to aztreonam, or beta-agonists.
•Use of any investigational drug, or device within 28 days of study entry (screening visit).
•Presence of a condition or abnormality that would compromise the subject's safety or the quality of study data, in the opinion of the investigator.

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