Fractional exhaled nitric oxide (FeNO) monitoring has been recommended for the management of difficult-to-treat and severe asthma in adolescent and adult patients by the Global Initiative for Asthma (GINA), according to Circassia Pharmaceuticals Inc.

During airway inflammation associated with allergic/eosinophilic asthma, higher-than-normal levels of nitric oxide (NO) are released from epithelial cells of the bronchial wall. Measuring the concentration of NO in exhaled breath, or fractional exhaled nitric oxide, can help identify airway inflammation. Circassia’s NIOX technology provides objective and accurate FeNO measurement of airway inflammation, and is the only FeNO testing device in the US available at point-of-care, the company says.

The new GINA guide recommends FeNO measurement as an assessment tool to determine whether patients who are on high-dose inhaled corticosteroids (ICS) or low-dose oral corticosteroids (OCS) have residual inflammation. This can provide a potential predictor of good response to anti-immunoglobulin E (anti-IgE) therapy for patients with severe, allergic asthma, and is a tool to identify refractory type 2 inflammation in patients on high-dose ICS therapy.

The guide suggests repeating FeNO measurement up to three times when asthma worsens before deciding if it is non-type 2. For patients with elevated type 2 biomarkers on high-dose ICS, FeNO monitoring is recommended to assess adherence before prescribing a biologic. Lastly, FeNO measurement is suggested as a means of monitoring tapering of oral corticosteroid treatment.

“The new GINA guidelines build on an earlier US Agency for Healthcare Research and Quality (AHRQ) report in terms of the strength of FeNO as a practical tool that improves outcomes for asthma patients. This GINA guide focuses on difficult-to-treat and severe asthma, which can be particularly devastating to patients and costly to the healthcare system in terms of physician visits, medication, hospitalization and management of treatment side effects. The strength of the guidance leaves no question about the role of NIOX in the successful diagnosis and management of asthma patients,” said David Acheson, senior vice president, US Commercial, Circassia.

Circassia recently announced that major insurer Aetna updated its policy to deem FeNO by NIOX as “medically necessary” as a part of comprehensive asthma diagnosis and management. Today, NIOX testing is considered affordable and accessible for both patients and their physicians, as an estimated 80 percent of American lives have insurance coverage for NIOX testing.