AZTREONAM LYSINATE FOR INHALATION IN CYSTIC FIBROSIS PATIENTS WITH PULMONARY P1

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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. Corus Pharma, Inc. is developing Aztreonam Lysinate for Inhalation (AI, Cayston¿), a unique lyophilized formulation of the monobactam antibiotic Aztreonam for the treatment of CF patients with Pseudomonas aeruginosa (PA). This study will evaluate the safety and efficacy of 28 days of TID treatment with 75 mg of AI. The AI formulation was developed for administration using the eFlow¿ Electronic Nebulizer, reducing treatment time and potentially improving patient compliance. This is a Phase 3; multi-center, multinational, double-blind, randomized, placebo-controlled study conducted in approximately 18 CF centers in the United States, 4 CF centers in Canada and 10 CF centers in Australia. The total study period will be approximately 56 days with five scheduled clinic visits. The study schedule will include a variable (up to 14 days) screening period, a mid-treatment visit at Day 14, an End of Treatment visit at Day 28, and an End of Study follow-up visit 14 days after the last dose of the study drug. All patients will self-administer their first dose of AI or placebo in the clinic, via the eFlow