Glossary of Terms

The following are definitions to many of the key terms used in this website:

Antibiotic

A class of medications used to treat infections caused by bacteria (germs). Antibiotics work by stopping or slowing the growth of bacteria.

Aztreonam

An antibiotic belonging to the monobactam class of antibiotics. Aztreonam is currently approved only for delivery by injection either into a vein (IV) or a muscle (IM).

Aztreonam lysine for inhalation

An experimental formulation of the antibiotic aztreonam that was created specifically for inhalation to treat Pseudomonas aeruginosa infection in the lungs of people with cystic fibrosis (CF).

Clinical trial

A research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. Different kinds of clinical trials include those that study prevention options, new treatments or new ways to use existing treatments, new screening and diagnostic techniques and options for improving the quality of life for people who have serious medical conditions. See the About Clinical Trials section to learn more.

eFlow^® Electronic Nebulizer

A handheld electronic nebulizer developed and manufactured by PARI Pharma GmbH, in cooperation with Gilead Sciences, Inc., for the administration of aztreonam lysine for inhalation.

Expanded access program (EAP)

The purpose of an EAP is to make experimental drugs available to those people most in need of treatment before the FDA approval process for the drug is complete. To be considered for an EAP, the drug must treat health problems that are serious or life-threatening in people with limited or no treatment options currently available to them. Click here to learn about other FDA considerations for an EAP.

Expectorate

To cough up mucus from the lungs.

Informed consent

The process of learning the key facts about a clinical trial before agreeing to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. The informed consent document is not a contract, so participants may withdraw from the trial at any time.

Intravenous (IV)

A method for administering drugs into the body via injection into a vein.

Intramuscular (IM)

A method for administering drugs into the body via injection into a muscle.

Monobactam

A class of antibiotics that includes aztreonam.

Nebulizer

A device that turns liquid medication into a fine mist so that it can be inhaled into the airways and lungs.

Phase I Clinical Trials

Early studies to determine how a drug is processed in people, the side effects associated with increasing doses of the drug and to potentially gain early evidence of how well a drug may work. Phase I Clinical Trials may include healthy participants and/or patients.

Phase II Clinical Trials

Clinical studies conducted to evaluate the effectiveness of the drug for a particular indication (use) or indications compared to another drug or placebo in people with the disease or condition under study. Phase II Clinical Trials also study any common short-term side effects and risks.

Phase III Clinical Trials

Larger trials conducted after preliminary evidence suggests effectiveness of the drug has been obtained in Phase II. Phase III Clinical Trials are intended to gather additional information to evaluate the overall benefit and risk of the drug to the patient population and provide an adequate basis for product labeling.

Protocol

A study plan on which all clinical trials are based. The plan is carefully designed to protect the health of the participants, as well as to answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

Pseudomonas aeruginosa

A type of bacteria (germ) that causes lung infections. Pseudomonas aeruginosa is the most common bacteria found in the lungs of people with CF.¹

Side effect

Any undesired actions or effects of a drug or treatment. Experimental drugs must be studied for both immediate and long-term side effects.

Sputum

Mucus coughed up from the lungs.