PHASE 3 STUDY EVALUATING AZTREONAM LYSIANTE FOR INHALATION IN CYSTIC FIBROSIS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究旨在评估28天使用氨曲南赖氨酸盐吸入(AI，Cayston TM)治疗囊性纤维化合并铜绿假单胞菌感染所致肺部疾病的安全性和有效性。该研究是一项双盲、随机、安慰剂对照、多国、多中心研究。患者将接受为期28天的治疗，由eFlow电子雾化器(EFlow)每天三次给予75 mg AI或容量匹配的安慰剂。将有5次预定的诊所就诊。这项研究将持续大约6周。其目标是对多达116名患者进行随机抽样。 本研究将评价75 mg阿魏酸钙治疗PA所致肺部疾病患者28天TID的安全性和有效性。主要终点是从第0天到第42天的FEV1中的更改。将进行中期分析，以评估该样本量所基于的假设 如有需要，样本数目将按需要增加至最多150名病人。符合条件的患者包括就诊前至少28天未使用抗假单胞菌抗生素的患者，且在就诊时预测有FSV1和Gt；25%至75%的CF和肺部PA感染。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is designed to assess the safety and efficacy of a 28 day treatment with Aztrenam Lysinate for Inhalation (AI, Cayston TM) in Cystic Fibrosis patients with lung disease due to Pseudomonas aeruginosa infection. The study is a double-blinded, randomized, placebo-controlled, multinational, multicenter study. Patients will receive 28 days of treatment with 75mg AI or volume-matched placebo administered three times daily by the Eflow Electronic Nebulizer (Eflow). There will be 5 scheduled clinic visits. The study will last approximately 6 weeks. The goal is to randomize up to 116 patients. This study will evaluate the safety and efficacy of 28 days of TID treatment with 75mg of AI in CF patients with lung disease due to PA. The primary endpoint is change in FEVl from Day0 through Day42. An interim analysis will be performed to assess the assumptions upon which this sample size is based; if necessary, the sample size will be increased as needed up to a maximum of 150 patients at that time. The eligibility criteria consists of patients > 6 years with CF and pulmonary PA infection with FSV1 >25% to <75% predicted at visit 1, who have not used antipseudomonal antibiotics at least 28 days prior to visit 1.