Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety)

Gilead Sciences, Inc.0 个研究点目标入组 60 人开始时间: 2015年2月2日最近更新: 2015年2月16日

适应症

试验速览

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•Aged 12 years or less.
•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 positive lower respiratory tract culture for PA at the screening visit plus 2 documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (start of treatment).
•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: 60
•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 14 days of study entry (start of treatment).
•Presence of a condition or abnormality that would compromise the participant’s safety or the quality of study data, in the opinion of the investigator.
•History of hypersensitivity/adverse reaction to aztreonam or beta-agonists.
•Use of any investigational drug within 30 days of study entry (start of treatment).

发起方