PHASE 3 STUDY EVALUATING AZTREONAM LYSIANTE FOR INHALATION IN CYSTIC FIBROSIS

点击翻译按钮获取中文摘要

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.