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FDA Clears New Test to Monitor Asthma
May, 2003

The Food and Drug Administration (FDA) has cleared for marketing a first-of-a-kind, non-invasive test system to measure the concentration of nitric oxide in exhaled human breath. The test system should help make it easier for doctors to monitor a patient's asthma.

Doctors can use the device in their office to evaluate their patient's response to anti-inflammatory treatment. A decrease in exhaled nitric oxide concentration suggests that the anti-inflammatory treatment may be decreasing the lung inflammation associated with asthma. Recent evidence has shown that nitric oxide levels are increased in the breath of people with asthma and that changes in nitric oxide levels may indicate whether or not treatment for asthma is working.

The test system, called the NIOX Nitric Oxide Test System, is made by Aerocrine AB, of Sweden. It combines equipment that detects nitric oxide and equipment that analyzes exhaled breath with a special computer system.

To use this new device, the patient places a mouthpiece, connected by a breathing tube to the computer, over his mouth. S/he inhales nitric oxide-free air to total lung capacity, then slowly exhales into the mouthpiece. The nitric oxide concentration is displayed immediately on the computer screen.

For more, visit the FDA website: The Food and Drug Administration (FDA) today cleared for marketing a first-of-a-kind, non-invasive test system to measure the concentration of nitric oxide in exhaled human breath. The test system should help make it easier for doctors to monitor a patient's asthma.

Doctors can use the device in their office to evaluate their patient's response to anti-inflammatory treatment. A decrease in exhaled nitric oxide concentration suggests that the anti-inflammatory treatment may be decreasing the lung inflammation associated with asthma. Recent evidence has shown that nitric oxide levels are increased in the breath of people with asthma and that changes in nitric oxide levels may indicate whether or not treatment for asthma is working.

The test system, called the NIOX Nitric Oxide Test System, is made by Aerocrine AB, of Sweden. It combines equipment that detects nitric oxide and equipment that analyzes exhaled breath with a special computer system.

To use this new device, the patient places a mouthpiece, connected by a breathing tube to the computer, over his mouth. S/he inhales nitric oxide-free air to total lung capacity, then slowly exhales into the mouthpiece. The nitric oxide concentration is displayed immediately on the computer screen.

For more, visit the FDA website: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01219.html