Clinical Trials

Cystic Fibrosis Study

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution versus Tobramycin Inhalation Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis

Protocol ID

09-02-147

Protocol Description

People with cystic fibrosis often have bacterial lung infections which occur repeatedly or worsen over time. Treatment with antibiotics is used to stop or slow down the growth of these bacteria, and may stabilize or improve the ability to breathe.The purpose of this research study is to compare the safety and effectiveness of two drugs - an experimental drug called Aztreonam and another drug called Tobramycin - in people with cystic fibrosis. Both of these drugs are antibiotics. Aztreonam is considered experimental for this study because, although it is approved by the FDA to be given intravenously, it is not approved to be given by inhalation. Tobramycin is approved by the FDA to be given both intravenously and by inhalation.

Eligibility Criteria

People with cystic fribrosis (CF)

Primary Investigator(s)

Rubin Cohen, MD

Contact Information

Li Chen Wann, NP
(516)465-5419
lcwann@nshs.edu

Last Update

April 2, 2010

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