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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究旨在评估因铜绿假单胞菌感染而导致肺部疾病的囊性纤维化患者吸入用赖氨酸阿兹曲南（AI，Cayston TM）治疗28天的安全性和有效性。本研究是一项双盲、随机、安慰剂对照、多国、多中心研究。患者将接受为期28天的75 mg AI或容量匹配的安慰剂治疗，每日三次，通过Eflow电子雾化器（Eflow）给药。将有5次计划的门诊访视。研究将持续约6周。目标是随机分配多达116名患者。 本研究将在患有PA所致肺部疾病的CF患者中评价75 mg AI TID治疗28天的安全性和疗效。主要终点是第0天至第42天FEV 1的变化。将进行中期分析，以评估该样本量的假设 基于;如有必要，将根据需要增加样本量，届时最多可增加至150例患者。合格性标准包括在访视1时具有CF和肺PA感染且FSV 1>25%至<75%预测值的> 6岁的患者，其在访视1前至少28天未使用抗假单胞菌抗生素。

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.