AVAIL is a Phase 3, randomized, double-blind, placebo-controlled study of the investigational drug AeroVanc (vancomycin hydrochloride inhalation powder) for persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis (CF) patients. The primary efficacy 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 (called “FEV1”), before and after treatment. The study is currently enrolling subjects in clinical research centers across the United States and Canada.
MRSA and Cystic Fibrosis
Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium that causes infections in the lungs of some CF patients. As the name implies, MRSA is resistant to some commonly used antibiotics, making it more difficult to treat than most strains of Staphylococcus aureus (often collectively referred to as “staph”). According to the Cystic Fibrosis Foundation, MRSA is found in about 25% of people with CF and studies have reported that infections caused by MRSA can become a long-term condition and even affect survival.1
What is AeroVanc and How Does it Work?
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, 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 adverse effects related to broad-spectrum antibiotics.
Previous Experience in CF
A previous Phase 2 study of AeroVanc in treating MRSA lung infections in people with CF, found that treated subjects had a significant reduction in MRSA density in their sputum compared to the placebo group (https://clinicaltrials.gov/ct2/show/NCT01746095). AeroVanc also showed encouraging trends in the trial’s secondary endpoints, including clinically meaningful improvements in pulmonary function, in respiratory symptoms, and in the time to exacerbation and need of other antibiotics, as compared to placebo.
What Are the Possible Risks or Side Effects That I Should Know About?
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.
Learn if participation in the AVAIL study is right for you. Additional information is available at ClinicalTrials.gov.
The AVAIL study is currently enrolling subjects, use our Site Finder to locate the participating clinical center nearest you.
The AVAIL study has been approved by the Institutional Review Boards at participating study centers. AeroVanc is an investigational drug. “Investigational” means that AeroVanc has not been proven to help patients with the disease you have and is not approved by the U.S. Food and Drug Administration (FDA).
Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association Between Respiratory Tract Methicillin-Resistant Staphylococcus aureus and Survival in Cystic Fibrosis. JAMA. 2010;303(23):2386–2392. doi:10.1001/jama.2010.791