EUCTR2015-000396-26-Outside-EU/EEA进行中（未招募）不适用
Expanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 603
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
- •> 6years of age
- •Patient has CF as diagnosed by one of the following:
- •- Documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test, or
- •-Two well characterized genetic mutations in the CFTR gene, or
- •- Abnormal nasal potential difference with accompanying symptoms characteristic of CF
- •PA present in expectorated sputum or throat swab culture within 2 months prior to consent
- •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:
- •-First Cohort Criteria:
- •Those who are waitlisted or eligible for lung transplant based on FEV1 criteria.
- •Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program.
- •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.
- •- Second Cohort Criteria:
- •Meets first cohort criteria; or
- •FEV1 < 40 % predicted at the time of consent
- •- Third Cohort Criteria:
- •Meets first or second cohort criteria; or
- •FEV1 < 50 % predicted at the time of consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 108
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 495
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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