Q: What is the AVAIL study and what is its purpose?
A: The AVAIL study is a Phase III, randomized, double-blind, placebo-controlled study of AeroVanc (vancomycin hydrochloride inhalation powder) for persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis (CF) patients. The primary endpoint of the AVAIL study will be evaluated by comparing the volume of air that a participant can force out in one second after taking a deep breath, an important measure of pulmonary function (also called “FEV1”), before and after treatment(s).
Q: What is the study drug?
A: AeroVanc is a powder form of vancomycin, self-administered using a reloadable capsule-based inhaler. Vancomycin, an antibiotic, has been widely used for more than 60 years to treat various bacterial infections. Vancomycin works by inhibiting bacterial cell wall synthesis, which stops the bacteria from multiplying and spreading. Vancomycin is an FDA-approved intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. However, when administered intravenously, poor penetration into the lungs and systemic toxicities limit its use as a chronic treatment. Because AeroVanc delivers vancomycin directly to the lungs, it is expected to improve clinical effectiveness and reduce systemic adverse effects.
The inhalation powder is packaged into capsules with each capsule containing 15 mg vancomycin. The dose is 2 capsules, twice a day. Alternatively, patients may be randomly selected to receive a matching placebo, with equivalent numbers of capsules.
Q: What Are the Possible Risks or Side Effects That I Should Know About?
A: You should consult with the study physician prior to and during participation in the AVAIL Study about your medical history and disease. The study physician has the most current information and can guide you in understanding any risks you face by participating in the AVAIL Study based on your clinical status. Your study physician can review the potential side effects with you before you enroll in the AVAIL Study.