Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients
The purpose of this research study was to evaluate the effectiveness, safety, and pharmacokinetics of AeroVanc compared to placebo (inactive substance) in subjects with cystic fibrosis (CF) and a chronic methicillin resistant Staphylococcus aureus (MRSA) lung infection.
Primary efficacy was measured by determining how much MRSA grows in the sputum of study subjects over time, but other efficacy measures included looking at changes in the subjects’ lung function (FEV1), changes in subjects’ respiratory symptoms, and whether other treatments are needed. Safety was measured in a variety of ways including changes in how a subject felt during the study, laboratory tests and physical examinations. Pharmacokinetics (PK) is the study of how the body absorbs, distributes, breaks down and eliminates a drug. This was measured using blood samples and sputum samples collected from adult study subjects.
Subject recruitment is now complete. Approximately 80 subjects were enrolled in this clinical study at approximately 40 study centers throughout the United States.
At a basic level, subjects must have a diagnosis of cystic fibrosis, be at least 12 years old and have evidence of persistent MRSA lung infection that is suspected to be causing health consequences in order to participate in the study.
The study consists of 7 visits over about a three-month period. The screening period lasts up to 2 weeks. After that, eligible subjects received study drug (AeroVanc or placebo; each subject has a 50% chance of being assigned to either treatment) for four weeks followed by an eight-week observation period. During the study, subjects were seen at regular intervals (every week during treatment except week 3, which is a phone visit; once a month during follow up) at one of the study centers for a variety of medical assessments such as pulmonary function testing, physical examinations and laboratory tests, all of which are at no cost.
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