Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression

Gilead Sciences, Inc.0 个研究点目标入组 45 人开始时间: 2015年2月3日最近更新: 2015年2月16日

试验速览

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•> 6 years of age
•Patient has CF as diagnosed by one of the following:
•-Documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis
•-Two well characterized genetic mutations in the CFTR gene, or
•-Abnormal nasal potential difference with accompanying symptoms characteristic of
•PA present in expectorated sputum or throat swab culture within 2 months prior to
•Patient must be able to provide written informed consent/assent prior to any study related
•procedure; parent/guardian must be able to give written informed consent as necessary
•prior to any study related procedure
•At high risk for disease progression as defined by one of the following patient
•populations:
•FEV1 < 50 00 predicted at the time of consent
•Completed participation in CP-Al-006 (through Visit 20). Patients who withdraw
•from CP-Al-006 prior to completing all courses of AZLI and all study visits will
•not be eligible for this protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements
•Patients with hypersensitivity to any of the components of the drug product
•Currently enrolled in another clinical trial
•Pregnant or lactating females

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