• Frequently Asked Questions

About Clinical Studies

Q: What is a clinic trial?

A: A clinical trial is a carefully designed investigation that is conducted with human participants to answer specific medical questions. In a clinical trial, which is supervised by research professionals, volunteers may receive an investigational medication which has not been approved for general use by the U.S. Food & Drug Administration (FDA). Clinical trials are conducted according to a study protocol, which specifies who may take part in the study, drugs to be administered and their dosing, testing and procedural schedules, and outcomes to be measured. Every volunteer participating in a study must agree to the protocol before enrolling by providing his or her informed consent. All aspects of a clinical trial must be approved by an Institutional Review Board (IRB), which exists to ensure that a clinical trial is ethical and the rights of study participants are protected.

Q: What is the purpose of a clinical trial?

A: The purpose of a clinical trial is to determine whether an investigational drug is safe and effective for treating a specific condition or disease. Some clinical trials are also designed to compare treatments already approved by the FDA to determine which is more effective, to study different ways to use standard treatments to increase effectiveness and/or decrease side effects, or to learn how to best use the treatment in a different group of patients in whom the treatment was not previously tested. The FDA determines if an investigational medication can be made available for use in clinical trials in the U.S.

Q: Should I participate in a clinical trial?

A: Participation in clinical trials is voluntary. Taking part in a clinical trial is an important decision and the decision to participate should be based on an informed choice made by the clinical trial participant. You should always consult with your doctor before deciding to participate in a clinical trial.

Q: What are the risks and benefits of participating in a clinical trial?

A: Participation in a clinical trial may permit you to access investigational therapies not otherwise available.  As in all clinical trials, the investigational medication being tested is new and there are risks. There may be side effects, which may be mild or serious, or the medication may not be effective. Speak with a study physician or research staff about the possible risks and benefits of participation in a clinical trial.

About AVAIL

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.

Ask your physician if you qualify for The AVAIL Study. To learn more, please visit the AVAIL study page at ClinicalTrials.gov

The AVAIL study has been allowed by the Institutional Review Boards at participating study centers.

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Information is intended for U.S. subjects and healthcare providers only.