Glossary

*ADEC*	Australian Drug Evaluation Committee
*agonist*	A molecule capable of combining with a biochemical receptor on a cell and initiating the same response as occurs naturally
*airway responsiveness*	The degree to which airways react to a stimulus. Usually used to describe the degree of airway constriction that will be caused by exposure to a stimuli
*analgesic*	Relieving pain; a pain-relieving drug
*antagonist*	A chemical that acts within the body to reduce the physiological activity of another chemical substancei.e. opposing the action of a drug or a substance occurring naturally in the body by combining with and blocking its receptor
*Aridol^TM*	Aridol™ is a patented, dry powder formulation of mannitol delivered to the lungs through an inhaler. Aridol™ is applied as a bronchial provocation test to accurately diagnose the presence and severity of bronchial hyper-responsiveness or over-sensitivity, which is characteristic of asthma.
*asthma*	Asthma is a serious condition in which the small airways of the affected person's lungs suddenly constrict when they are exposed to certain triggers. Airflow into and out of the lungs is reduced, and the person has to gasp for breath.
*autoimmune*	Having the property whereby immune cells respond to tissues in ones' own body.
*beta interferon*	A protein released by connective tissue cells in response to a viral infection. The protein can be synthesised and used in the treatment of multiple sclerosis
*breakdown products*	Products that result from the disintegration or decomposition of a substance in the body
*bronchial hyper-responsiveness or over-sensitivity*	When a person's bronchial tubes (tubes that lead to the left and right lung) are abnormally responsive or sensitive to triggers and react by narrowing and becoming inflamed
*bronchial provocation test*	A lung test that provokes a temporary narrowing of the bronchial tubes in the lungs
*bronchiectasis*	A form of chronic obstructive pulmonary disease (COPD) characterised by irreversible dilation and destruction of the bronchial walls
*Bronchitol^TM*	Bronchitol™ is a patented, dry powder formulation of mannitol delivered to the lungs through an inhaler. Bronchitol™ is designed for the treatment of diseases such as COPD and cystic fibrosis.
*bronchodilator*	A substance that acts to dilate or expand the bronchial airway passages, making it easier for patients to breathe
*carcinogenicity*	Potential to cause cancer
*central nervous system*	System of nerves of the brain and spinal cord
*chemoattractant*	A chemical agent that induces movement of cells in the direction of its highest concentration
*chest percussion*	Form of physiotherapy/massage that involves tapping the patient's chest with light, rapid blows to help them expel mucus from their lungs
*chronic*	A disease or condition of long duration or frequent recurrence; in some instances, it may slowly become more serious over time
*chronic bronchitis*	One of the most common forms of chronic obstructive pulmonary disease (COPD), characterised by persistent airway inflammation, with symptoms including a chronic cough producing mucus, and shortness of breath.
*chronic obstructive pulmonary disease*	A group of lung diseases characterised by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema, chronic bronchitis and bronchiectasis are forms of chronic obstructive pulmonary disease. Abbreviated as COPD.
*cilia*	Millions of fine hair-like structures that cover the inside lining of our airways and move continuously to propel secretions up to the throat (also see mucociliary clearance )
*clinical trial*	Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section
*COPD*	Refer to chronic obstructive pulmonary disease
*corticosteroids*	Any of the steroid hormones produced by the adrenal cortex or their synthetic equivalents. Corticosteroids are used clinically for hormonal replacement therapy, for suppression of adrenocorticotrophic hormone (ACTH) secretion by the anterior pituitary, as anti-cancer and anti-allergic and anti-inflammatory agents and to suppress the immune response. They may be injected, taken as pills, inhaled via a puffer or rubbed on to the skin.
*cystic fibrosis (CF)*	Cystic fibrosis (CF) is an inherited, life-limiting disease that affects the body's exocrine glands, causing them to secrete fluids that are poorly hydrated and therefore thicker and stickier than fluids in people without CF. This leads to chronic problems in various systems of the body, particularly the lungs.
*dose response curve*	A dose response curve illustrates the relation between the amount of a drug or other chemical administered to a person or an animal and the degree of response it produces.
*dosing phase*	Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section
*endothelial*	An endothelial cell layer refers to the layer of cells that lines the blood vessels and airways
*epithelial mast cells*	Mast cells are a variety of Leukocytes or white blood cells containing granules which store a variety of inflammatory mediators including histamine and serotonin. Mast cells play a central role in inflammatory and immediate allergic reactions. The extracellular release of the mediators is known as degranulation and may be induced by the presence of a specific antigen (allergen). Epithelial mast cells are those found in the epithelium (the membranous tissue composed of one or more layers of cells separated by very little intercellular substance and forming the covering of most internal and external surfaces of the body and its organs. Skin and the lung linings are two examples of epithelium.)
*eucapnic hyperpnoea*	Eucapnic (adjective) is defined as a normal healthy level of carbon dioxide (C0₂).Hyperpnoea is abnormally fast breathing.
*exercise challenge test*	A test in which patients undertake a physical activity, such as bike riding, and the body's response to the activity is measured. It can be used to determine if a patient is asthmatic by measuring the degree of bronchial constriction that is induced during a period of exercise.
*exocrine glands*	Glands that produced mucus, saliva, sweat and tears
*FDA*	United States of America's Food and Drug Administration
*flare or flare-up*	Period of worsening symptoms
*head-to-head trial*	A clinical trial in which a test compound is evaluated against another compound
*hypertonic saline*	A solution with a higher salt concentration than in normal cells of the body and the blood. A salt solution containing more than 0.9% salt is hypertonic.
*International Committee on Harmonisation (ICH)*	An international body that provides test guidelines that cover the manufacture of drug substances, the manufacture of the dosage form, and the safety testing that must be conducted before evaluation in humans can proceed.
*in vitro*	In an artificial environment, outside the living body e.g. in a test tube
*in vivo*	In the living body of a plant or animal, or in real life
*leukocytes*	Immune cells; white blood cells
*ligand*	A molecule that binds to cell receptors
*lung function*	Ability of a person to move air in and out of their lungs. A measure often used is termed FEV1, which is the volume of air that can be forcibly expelled from the lungs in one second
*lymphocyte*	A type of white blood cell found in the body's lymph, a clear fluid that flows through the body and has an important function in defending the body against disease
*mannitol*	Mannitol is a naturally occurring sugar used variously as a food additive, a therapeutic product, and a sweetener.
*marketing authorisation*	The legal authority granted to an individual or company to sell a product
*meta-analysis*	Pooling and examining data from a number of studies
*methacholine inhalation test*	A test used to diagnose asthma. Aerosolised methacholine is inhaled and causes bronchial constriction in asthmatic patients
*mucociliary clearance*	A constant, natural process where the cilia lining the lungs move continuously and propel the overlying blanket of salt, water and mucus up to the throat, where secretions are swallowed or expelled as sputum. This helps keep the airways clean, allows the passage of clean, warm air through the lungs, and removes any foreign bodies from the airways, preventing infection.
*mucosal hydration*	The natural process of keeping mucus hydrated to prevent it becoming thick and sticky i.e. maintaining the correct balance of water
*mucus*	Thin, slippery substance secreted by the lungs (and other organs in the body) to defend against germs, dust particles and other foreign bodies
*multi-centre study*	Study conducted simultaneously in a number of clinics, hospitals, etc
*multiple sclerosis (MS)*	A chronic, debilitating disease of the central nervous system in which the immune system attacks and damages the myelin around the nerve cells, causing signals to the brain and spinal cord to be slowed or halted
*myelin*	The protective protein sheath that insulates the nerve cells and helps speed the conduction of nerve signals to the brain and spinal cord
*nebulised medication*	Medication delivered to the lungs of patients in fine spray by aerosol or face mask
*oral medication*	Medication taken by mouth e.g. tablets, liquids
*osmotic balance*	Osmosis is the passage of water from a region of high water concentration through a semi-permeable membrane to a region of low water concentration. Osmotic balance is when there is no tendency for water to flow across the membrane.
P3	Pharmaceutical Partnerships Program (Australian Federal government grant program)
*pathogen*	Disease-causing microorganism
*PBS*	Pharmaceutical Benefits Scheme (Australian government program that reduces the cost of some drugs to patients)
*PCT*	Patient Cooperation Treaty
*pharmaco-economic evaluation*	Evaluation of the potential of a new pharmaceutical product to produce cost savings to a national economy
*pharmacokinetic profile*	How a drug interacts in the body in terms of its absorption, distribution, metabolism, and excretion
*phase III registration study*	Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section
*phase II clinical trial*	Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section
*pilot clinical study*	Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section
*placebo*	An inert or innocuous substance used especially in controlled experiments to test and compare the efficacy of another, active, substance
*postural drainage*	A method of draining the lungs in which the patient is placed in an inverted position so that fluids are drawn by gravity
*pre-clinical*	Prior to being administered to volunteers or patients
*protease*	An enzyme that breaks the internal bonds of a protein
*psoriasis*	A chronic skin disease characterised by red patches covered with white scales
*pulmonary function*	See lung function
*pulmonary system*	Lungs
*pyrans*	A sugar derivative
*PXS25/64*	A compound being developed by Pharmaxis to target the underlying disease processes of multiple sclerosis
*PXS2076*	A compound being investigated by Pharmaxis for its effects on rheumatoid arthritis, particularly in inhibiting the inflammatory proteins that cause inflammation and tissue destruction.
*R&D*	Research and development
*relapse*	A recurrence of symptoms of a disease after a period of improvement or remission
*remission*	Period when the symptoms of the patient's disease are not present
*respiratory failure*	A clinical term used to define the inability of the lungs to function
*respiratory insufficiency*	A clinical term used to define a failure to adequately provide sufficient oxygen to the body, or remove excess carbon dioxide
*rheology*	The study of the flow of materials that behave in an interesting or unusual manner
*rheumatoid arthritis*	A form of arthritis characterised by an immune response to one's own body, usually manifesting as inflammation and stiffness of the joints. Progressive forms of the disease may lead to serious joint damage, painful deformity, and disability.
*safety profile*	Evidence gathered that indicates a substance is safe to be administered to people
*secondary lung infections*	Infection coming after, or as a result of, an initial or primary infection
*selective inhibitor*	A substance that is used to stop a specific biochemical reaction
*spirometer; spirometry test*	A device used to measure the amount of air a patient can expel from their lungs in one second
*sputum microbiology*	A measure of lung infections
*statistical significance*	A mathematical test that indicates that groups being compared are different
*steroid*	Numerous natural or synthetic compounds that contain a 17-carbon 4-ring system and can modify reactions in the body
*synthesis, synthetic compound*	A substance that is made by a series of chemical or biochemical reactions
*T-cells*	Immune cells that attach themselves to other cells
*therapeutic*	Medicinal, curative
*TGA*	Australian Therapeutic Goods Administration
*toxicology study*	Investigation into the adverse effects of a substance in an animal or human
*Tumour Necrosis Factor (TNF)*	A small molecular-weight protein produced primarily by immune cells. It is a key protein responsible for initiating inflammation
*viscosity*	A physical property of fluids that determines the internal resistance to shear forces (the resistance a material has to change in form)

Also refer to our guide to the Clinical Trial, Regulation & Approvals Process