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The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic Asthmatic Adults and Children.
Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airways are exposed to various risk factors. Asthma causes recurring episodes of wheezing, breathlessness, chest tightness, and coughing particularly at night or in the early morning.
NO is an important endogenous regulatory molecule that is widely distributed throughout the body. The detection of NO in exhaled air was first reported in 1991, and, soon after it was shown that the levels NO in exhaled air are elevated in patients with asthma. There is now much evidence showing that measurement of the concentration of NO in exhaled air offers a useful non−invasive method of assessing inflammatory airway disease.
Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation. Exhaled NO may have a valuable role in differentiating between the inflammatory and bronchospastic components of clinical asthma, and is also useful for guiding the therapeutic use of steroids and other anti−inflammatory agents.
A study on asthmatics and non−asthmatics subjects has shown that substantial equivalence exists between the stationary device NIOX® and the hand held device NIOX MINO® when comparing NO measurements, when similar conditions are considered and examinations are made as consistently as possible.
In a study with the stationary device NIOX®, exhaled NO was measured before and after two weeks of inhaled corticosteroid treatment in unstable steroid−naïve adult and paediatric asthmatic subjects. The result was a 50.5% mean reduction of exhaled NO. The change in exhaled NO was also compared to change in standard asthma outcome measures, asthma symptoms and spirometry.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
The Aerocrine NIOX MINO® Airway Inflammation Monitor
Näsets Läkargrupp, Falsterbov. 79, SE-23651 Höllviken
Published on BioPortfolio: 2014-08-27T03:42:02-0400
Collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared NIOX eNO Breath...
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A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).
Asthma attacks following a period of exercise. Usually the induced attack is short-lived and regresses spontaneously. The magnitude of postexertional airway obstruction is strongly influenced by the environment in which exercise is performed (i.e. inhalation of cold air during physical exertion markedly augments the severity of the airway obstruction; conversely, warm humid air blunts or abolishes it).
Thermal destruction of the excess bronchial SMOOTH MUSCLE tissue with heat delivered through a catheter assembly attached to a BRONCHOSCOPE. It is often used to control BRONCHIAL HYPERREACTIVITY in severe ASTHMA for better AIRWAY MANAGEMENT.
The structural changes in the number, mass, size and/or composition of the airway tissues.
Evaluation, planning, and use of a range of procedures and airway devices for the maintenance or restoration of a patient's ventilation.
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